Attachment D - List of Sealed Source and Device Cases by … · Ret'd from Fees 5/11/2001. Def. ltr...

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Attachment D Section 1 of 4 List of SS&D Cases Completed between 9/10/2001 - 9/30/2002 (listed in order of completion date)

Transcript of Attachment D - List of Sealed Source and Device Cases by … · Ret'd from Fees 5/11/2001. Def. ltr...

Page 1: Attachment D - List of Sealed Source and Device Cases by … · Ret'd from Fees 5/11/2001. Def. ltr sent 6/15/2001. Def. ltr. placed in ADAMs - ML011660407. Closed 9/19/2001. NR-1081-S-101-S

Attachment DSection 1 of 4

List of SS&D Cases

Completed between 9/10/2001 - 9/30/2002

(listed in order of completion date)

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Sealed Source & Device ActionsFor Fiscal Year 2002

MSIB-A StatisticsMonth Received Completed Pending

October 3 3 18November 5 6 17December 33 5 45January 16 31 30February 8 14 24

March 5 4 25April 10 4 31May 4 10 25June 3 9 19July 3 7 15

August 2 4 13September 3 1 15

TOTALS 95 98 15

Fee Statistics FeeCategory

Total Actions Requiring Fees Not Requiring Fees

Pending*

Completed Pending* Completed Pending* Completed

9AA 82 87 14 16 68 71

9AN 10 7 9 7 1 0

9BA 0 0 0 0 0 0

9BN 0 0 0 0 0 0

9CA 1 1 0 0 1 1

9CN 2 3 2 3 0 0

9DA 0 0 0 0 0 0

9DN 0 0 0 0 0 0

Totals 95 98 25 26 70 72* Pending Actions under Fee Statistics only includes Fiscal Year data. Materials Safety and InspectionBranch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Date Completed

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CompanyModel Numbers Status

09/14/2001 01-36 Burgess

1 Kidde Fenwal, Inc. CPD 702X Series, CPD 704XSeries, CPD 705X

Name Change Only!!! Changing name from "WalterKidde & Company" to Kidde-Fenwal, Inc.M. Burgess is 1st reviewer.J. Jankovich will be 2ndreviewer.To Fees 8/24/2001.Closed 9/14/2001. No changeneeded since name changewas made on April 27, 1992 to NR-668-D-101-E.

09/17/2001 01-20 Ward 1 United Technologies LTG1 Request to inactivate NR-655-

D-101-S.Bill Ward to review, JohnJankovich will be a revieweras well as Seung Lee.To Fees 4/16/2001.Ret'd from Fees 4/20/2001.Acceptance review completed4/30/2001.Closed 9/17/2001. NR-655-D-101-S inactivated to NR-655-D-801-S.

09/19/2001 01-26 Jankovich

1 Mills Biopharmaceutical, NER-004R Request to amend NR-1081-S-101-S to add an isotopeusing Palladium-103.To Fees 5/9/2001.Ret'd from Fees 5/11/2001.Def. ltr sent 6/15/2001. Def.ltr. placed in ADAMs -ML011660407.Closed 9/19/2001. NR-1081-S-101-S amended in itsentirety.

1 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Date Completed

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Reviewer

CompanyModel Numbers Status

10/16/2001 01-27 Lee 1 Sensor Applications,

Inc. M90 Chemical Detector

Request for radiation safetyevaluation & registration of theEnvirionics Chemical DetectorUnit (M90).To Fees 5/23/2001.Application Fee in amount of$1200.00 paid anddated5/16/2001. Ck #3693.Acceptance review ok -6/14/2001.Def. ltr given to M. Burgess forreview 6/15/2001.Def. ltr sent out 9/13/2001.No response rec'd to J.Hickey's ltr of 9/13/2001(ML012550087).Closed out 10/16/2001.Will open new case whenresponse rec'd.

10/24/2001 01-42 Kirkwood

1 Stocker Yale 100/1 Request to inactivateNR-622-D-101-E. Tony Kirkwood will be SSDreviewer. John Jankovich willbe 1st reviewer & Seung Leewill be 2nd reviewer.Ret'd from Fees 10/17/2001.Case voided 10/24/2001. Inactivated 5/3/2000, signedby U. Bhachu & J. Jankovich. NR-622-D-101-E ML003710693 (certificate),ML011940371 (Letter),Package ML011660405 (3documents) orML011790571(2 documents) .

2 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

10/24/2001 01-28 Lee 1 Lite Pro Tekolite Application for evaluation &

registration of an SSDcontaining gaseous tritiumlight sources.Check #1050112530 for$5,200.00 paid.To Fees 5/24/2001.Incoming sent to DCD forscanning. Accession Numberis: ML011510285.Def. letter sent 7/5/2001. ML011860048.2nd Def. letter sent 8/1/2001for add'l info on TeknoliteFlashlight.Closed 10/24/2001. Reason: We cannot issue theregistration certificate untilTicket #WITS 2001100028,NMSS 2001100136 iscompleted. Ticket due date toIMNS is 11/20/01, but the fullresolution of the issue will takelonger. Resolution isundetermined at this time. Wecannot keep SSD caseopened indefinitely.A letter was sent to Mr. Tchiraand the State of Florida onJanuary 23, 2002. Also sentwas registration certificate NR-1145-D-101-E & License 09-23879-01E.

11/01/2001 01-41 Burgess

1 Met One Instruments E-BAM Request to for a new device.Check number 036061 rec'd inthe amount of $5,400.00.1st reviewer: M. Burgess2nd reviewer: J. JankovichRet'd from Fees 9/21/2001.Case rejected and closed out11/1/2001. Letter sent to RonSiebert rejecting application11/1/2001.

3 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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CompanyModel Numbers Status

11/09/2001 01-21 Ward 1 MDS Nordion GammaMed 212

Request to obtain registrationfor GammaMed 212 sealedsource for MDS Nordion.To Fees 4/20/2001.Acceptance review completed4/30/2001.Returned from Fees May 17,2001. Fees rec'd applicationcheck for $1600.00 (Ck#2051010).Add'l information received6/21/2001.Sent to DPC for scanning ofadd'l info 6/21/2001.Closed 11/9/2001. Certificateissued: NR-220-S-124-S.

11/09/2001 01-23 Ward 1 DraxImage Brachyseed Pd-103 Model Pd-1

Closed 11/9/2001. Certificateissued: NR-1121-S-102-S.

11/09/2001 01-39 Ward 1 MDS Nordion 12i & 12it Brachytherapy Device

Amendment to NR-220-D-121-S for the GammaMed 12i and12it brachytherapy device toadd the GammaMed 212sealed source.To Fees 9/10/2001.Ret'd from Fees 9/21/2001.Closed out 11/9/2001. Amended certificate NR-220-D-121-S. ML012630192.

11/27/2001 01-30 Lee 1 eV Products CPC-48 thickness gauge

Application for deviceregistration of the CPC-48thickness gauge.ADAMs number: ML011580428.To Fees 6/12/2001.Acceptance review ok -6/20/2001.Ret'd from Fees 7/2/2001.Case rejected 11/27/2001.Rejection letter sent out toBruce Glick and Doug McAbeeon 11/27/2001.

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4 Materials Safety & Inspection Branch

Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

11/30/2001 01-43 Lee 1 Molins Richmond, Inc. "Maid N" Request to inactivate NR-462-

D-102-B.To Fees 10/30/2001.1st: Seung Lee2nd: John JankovichClosed 11/30/2001. NR-462-D-803-B (supercedes NR-462-D-102-B).Ret'd from Fees 11/30/2001.

12/05/2001 01-46 Kime 1 iTi Qualitek, Inc. Leakmeter 200

Address change only!!!To Fees 11/30/2001.Closed 12/5/2001.NR-1128-D-101-E amended toreflect address change.Package Number: ML013390111.Ret'd from Fees 12/20/2001.

12/07/2001 01-29 Ward 1 MDS Nordion C-168 SSD Registration for MDS

Nordion C-168.Michele Burgess 1st revieweralso. Sent to DPC for scanning6/12/2001.Folder created in ADAMs6/12/2001. Sent to Fees 6/12/2001.Ret'd from Fees 7/2/2001.Case terminated December10, 2001. Phone call withMarc Charette December 4,2001, stating that he could notget to review in time for 30-dayresponse period, therefore;case is terminated until furthernotice. Review will continueonce response is received,probably January 2002.

5 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Date Completed

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Reviewer

CompanyModel Numbers Status

12/10/2001 01-44 Lee 1 Sensor Applications,

Inc. M90 Amendment to the Envirionics

Chemical Detector Unit M90.Sent in revised application forthe M90, the users manual,the Finnish radiationmeasurements and acomparison with the 1995version.Previous SSD Case 01-27.To Fees 11/20/2001Ret'd from Fees 12/4/2001.Closed 12/10/2001. Incomplete application. Willresubmit.

12/10/2001 01-32 Ward 1 MDS Nordion GammaMed 232

Request to amend NR-220-S-123-S. 1st reviewer Bill Ward & S.Lee.2nd reviewer John Jankovich.Sent to DPC for scanning6/21/2001.Nima Ashkeboussi will beworking on part of this with BillWard.Acceptance review ok6/28/2001.Ret'd from Fees 7/2/2001.ADAMs Accession Number: ML011830071.Closed 12/10/2001. Amendedcertificate NR-220-S-123-Sissued 12/10/2001.

6 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

12/14/2001 01-31 Burgess

1 MDS Nordion C-442 Request for new application ofa C-442 sealed source. Nima Ashkeboussi will be a1st reviewer along with M.Burgess.J. Jankovich 2nd reviewer.Transferred from Nima toMichele on 8/23/2001. JohnJankovich will still be secondreviewer.To Fees 6/19/2001.Def. ltr sent 11/13/2001.OGC acceptance of affidavit -12/12/2001.Closed 12/14/2001. Issuanceof Letter to Marc-AndreCharette and registrationcertificate NR-220-S-126-S. Michele to place in ADAMssoon.

01/03/2002 01-35 Burgess

3 IMX, LLC Various Request to inactivate:NR-352-D-101-E, NR-352-D-102-E & NR-352-D-103-E.M. Burgess 1st reviewer, J.Jankovich 2nd reviewer.To Fees 8/20/2001.Ret'd from Fees 8/21/2001.Def. ltr sent 9/5/2001.Def. resp. rec'd 11/20/2001.Closed 1/3/2002. Certificatesinactivated to: NR-8126-D-801-E, NR-8126-D-802-E, &NR-8126-D-803-E.

7 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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01/17/2002 01-49 Lee 1 Dept. of the Army FHP 200 Application for a new device

(instrument calibrator)Seung Lee 1st reviewerUjagar Bhachu 2nd reviewerTo Fees 12/6/2001.Sent to ADAMs to scan extracopy 12/6/2001 in SeungLee's name.Engineering drawings wereunavailable so we were unableto complete review. Seung iskeeping file with him until theyrespond back.Closed 1/17/2002.Ret'd from Fees 3/5/2002.

8 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Date Completed

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Reviewer

CompanyModel Numbers Status

01/23/2002 01-52 Ashkeboussi

25 MDS Nordion Various Name change on deviceregistrations:NR-220-D-101-S thru 103-S,NR-220-D-105-S thru NR-220-D-108-S, NR-220-D-111-Sthru NR-220-D-124-S.Nima & Michele 1st reviewersJohn J. - 2nd reviewerTo Fees 12/19/2001Ret'd from Fees 1/22/2002.Closed out 1/23/2002. Allcertificates were amended intheir entirety to reflect nameand address correction. Certificates amended:

NR-220-D-101-S, NR-220-D-102-S, NR-220-S-103-S, NR-220-D-105-S, NR-220-D-107-S, NR-220-S-108-S, NR-220-S-111-S, NR-220-S-112-S,NR-220-D-113-S, NR-220-D-114-S, NR-220-S-115-S, NR-220-S-116-S, NR-220-D-117-S, NR-220-D-118-S, NR-220-S-119-S, NR-220-S-120-S,NR-220-D-121-S, NR-220-D-122-S, NR-220-S-123-S, NR-220-S-124-S, NR-220-S-126-S, NR-220-S-801-S, NR-220-D-802-S, NR-220-S-803-S, &NR-220-S-804-S.

Package Number: ML020250121 is for NR-220-D-105-S.Package Number: ML020250468 is for NR-220-S-108-S.Package Number: ML021780137 is for NR-220-S-112-S.ML021780176 - NR-220-S-124-SML021780170 - NR-220-S-123-SML021780152 - NR-220-S-115-SML020250468 - NR-220-S-108-S

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ML021780154 - NR-220-S-116-SML020250478 - NR-220-S-111-SML021780137 - NR-220-S-112-SML021780158 - NR-220-S-119-SML021780154 - NR-220-S-116-SML021780149 - NR-220-D-114-SML021780155 - NR-220-D-117-SML021780162 - NR-220-D-121-SML021780157 - NR-220-D-118-SML021780142 - NR-220-D-113-SML020250098 - NR-220-S-103-SML020250133 - NR-220-D-107-SML021780164 - NR-220-D-122-SML020240057 - NR-220-D-101-SML020250121 - NR-220-D-105-SML020250071 - NR-220-D-102-SML021780216 - NR-220-S-804-SML021780181 - NR-220-S-126-SML021780186 - NR-220-S-801-SML021780159 - NR-220-S-120-S

9 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Date Completed

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Reviewer

CompanyModel Numbers Status

01/24/2002 01-47 Ashkaboussi

1 Electronic Systems spa

Sintel 9000 Amendment to registrationcertificateNR-1055-D-101-S.M. Burgess and N.Ashkabousi are 1st reviewers.J. Jankovich 2nd reviewer.To Fees 11/30/2001.Ret'd from Fees 12/20/2001.Closed 1/24/2002. Letter sentto Ed Weiss of Opti-Filmsenclosing a draft registrationcertificate NR-1055-D-101-Swith corrections.

01/24/2002 01-48 Ashkaboussi

1 TSI Incorporated 3012, 3012A, 3013, 3054,3054A, 3077, 3077A

Amendment to registrationcertificateNR-636-D-101-G.M. Burgess and N.Ashkabousi are 1st reviewers.J. Jankovich 2nd reviewer.To Fees 11/30/2001.Ret'd from Fees 12/20/2001.Closed 1/24/2002. Letter toJeff Swanson of TSIIncorporated enclosing draftregistration certificate NR-636-D-101-G with corrections.Final registration certificateNR-636-D-101-G sent out1/30/2002.ML020290507

10 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

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02/13/2002 02-02 Kime 13 Aptec/NRC Various Request to change the

following certs:NR-504-D-801-G thru NR-504-D-813-G.Name Change Only!!!1st reviewer: Traci Kime2nd reviewer: John Jankovich& S. LeeTo Fees 1/14/2002.Ret'd from Fees 1/22/2002.Completed letter andcertificates given to JohnJankovich 1/30/2002 forreview.Closed out 2/13/2002. Certificates NR-504-D-801-Gthru NR-504-D-813-G.Each certificate has own folderand own accession number.

11 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

02/22/2002 01-37 Bhachu

1 Scan Technologies CM-100 Re-submission of SSDrequest which was withdrawnon July 2, 2001.

Requesting review for theSpecific Licensed devicecontaining by-product material,submitted in duplicate.To Fees 8/29/2001.M. Burgess 1st reviewer, J.Jankovich 2nd reviewer.Ret'd from Fees 11/8/2001.Transferred to Ujagar Bhachuas 1st reviewer 1/30/2002.Application dated August 8,2001, was assigned toMichele Burgess as the firstreviewer. On January 29,2002, this case was assignedto Ujagar as a first reviewer. According to Michele, deviceprototype testing has not beenreviewed and some otherissues need resolution. Ujagar will have to acquainthimself with the contents ofthe application and the historyof this case prior to thecompletion of the RAI. This case will not becompleted within 180 days.Larry Campbell and JohnJankovich are aware of it.Case discontinued 2/22/2002due to lack of significantamounts of information.

03/09/2002 02-06 Bhachu

1 TSI Incorporated 3012, 3013, 3054, 3077, 3078,3012A, 3054A

Request to amend Krypton-85neutralizer models under NR-636-D-101-G.To Fees 2/11/2002.Ret'd from Fees 3/5/2002.Closed out 3/9/2002. NR-636-D-101-G amended in itsentirety.

12 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

For actions recorded as of Tuesday, July 26, 2005Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

03/19/2002 02-11 Jankovich

1 Cammenga &Associates, Inc

watches & timepieces

Request to amend materialslicense.Case closed out 3/19/2002. Application rejected.Ret'd from Fees 3/26/2002.

03/20/2002 01-50 Bhachu

1 Met One Instruments E-Bam Notification of lifting copyrightoff the E-Bam OperationalMaual.1st reviewer: Ujagar Bhachu2nd reviewer: John JankovichRet'd from Fees 12/20/2001.Def. ltr sent 1/31/2002. ADAMS ML#020310145.Closed 3/20/2002. Issuednew certificate for Met One. NR-1124-D-102-E.

03/26/2002 02-14 Bhachu

1 Dept. of the Army M43A1 Administrative/typographicalerror noted in registrationcertificate NR-1129-D-102-S. Certificate amended in bold toreflect errors.To Fees 3/26/2002.Closed out 3/26/2002.Ujagar to place in ADAMs. ADAMs number: ML020640453.Ret'd from Fees 4/1/2002.

04/03/2002 02-13 Ashkeboussi

1 Lite Pro Teknolite 2 & Teknolite 4

Request to amend NR-1145-D-101-E to reflect a secondaddress for the manufacturerKeen Tools, Inc.1st reviewer: Seung Lee2nd reviewer: John JankovichTo Fees 3/22/2002.Ret'd from Fees 4/1/2002.Closed out 4/3/2002. Amended NR-1145-D-101-E -ML020910031.

13 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

04/03/2002 01-40 Jankovich

1 MDS Nordion TheraSphere Y-90 GlassMicrospheres

Application rec'd 9/7/2001,however; it was not assigneduntil 9/14/2001 due to SS&DIMPEP the week of 9/10/2001.Amendment to NR-220-D-113-S for TheraSphere Y-90 GlassMicrospheres.To Fee 9/14/2001.1st reviewer: J. Jankovich2nd reviewer: S. LeeRet'd from Fees 9/21/2001.Acceptance review completedand accepted 9/25/2001.Def. ltr sent 2/8/2002.Def. response rec'd 3/5/2002.Prop. ltr sent out 4/2/2002.Closed out 4/3/2002. Issuance of NR-220-S-113-S. ML020930629.

04/03/2002 02-07 Lee 1 MDS Nordion C-164 Request to re-activate and

update SSD NR-169-S-801-Ufor the C-164 sealed source.To Fees 2/14/2002.Acceptance review performed2/19/2002 and found to be ok.Def. ltr sent out 2/26/2002.Ret'd from Fees 3/5/2002.Closed out 4/3/2002. Issuance of NR-220-S-127-S. ML020930469.

04/22/2002 02-19 Jankovich

1 MDS Nordion TheraSphere

Request to amend NR-220-S-113-S.To Fees 4/17/2002.Ret'd from Fees 4/25/2002.Closed out 4/22/2002. Amended registrationcertificate NR-220-S-113-S.

14 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

05/08/2002 01-45 Kirkwood

1 Tyco ElectronicsProduct

ISO 9001 Application for SSD. Checkfor $5400.00 rec'd 11/19/2001. Check #700034.To Fees 11/20/2001.Ret'd from Fees 12/4/2001.Def. ltr sent 12/20/2001requesting add'l info.

MS 16, deficiency reponsereceived 1/29/02MS 14, RAI, request foradditional information dated2/11/2002MS16, deficiency responserec'd 3/28/02.Closed 5/8/2002. Registrationcertificate NR-1156-D-101-E(Superceded NR-776-D-102-E) & License 20-23881-01E.Package Number: ML020020185

05/13/2002 02-09 Lee 1 21st Century

Technologies RDI111, RBI010, SIC123,GKF001, GKR010 etc.

Amendment to NR-365-D-101-E.To Fees 3/5/2002.1st reviewer: Seung Lee2nd reviewer: John JankovichRet'd from Fees 3/8/2002.Closed 5/13/2002. NR-365-D-101-E amended in its entirety.

15 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

05/17/2002 01-16 Burgess

3 Agilent Technologies Various Amendments to:NR-348-D-106-B, NR-348-D-109-B, NR-348-D-111-B.To Fees 3/9/2001.Ret'd from Fees 3/13/2001.Def. ltr sent out 8/28/2001.Def. response rec'd Oct. 2001,Jan. 2002.Def. ltr sent 1/28/2002.Def. response rec'd 2/26/2002via Fed Ex.Closed out 5/17/2002.New issuance of NR-348-D-805-B which superceded NR-348-D-106-B & 107-G, NR-348-D-109-B which wascombined with NR-348-D-110-S & NR-348-D-111-B wereboth amended in their entirety. Michele to place in ADAMssoon.

05/17/2002 01-51 Burgess

1 Agilent Technologies ECD Request to inactivate NR-348-D-106-B.1st reviewer: M. Burgess2nd reviewer: J. JankovichTo Fees 12/11/2001.Ret'd from Fees 12/20/2001.Def. ltr sent 8/28/2001.Def. response rec'd Oct. 2001& Jan. 2002.Def. ltr sent 1/28/2002.Def. response rec'd 2/26/2002via Fed Ex.New issuance of NR-348-D-805-B which superceded NR-348-D-106-B & 107-G, NR-348-D-109-B which wascombined with NR-348-D-110-S & NR-348-D-111-B wereboth amended in their entirety. Michele to place in ADAMssoon.Closed out 5/17/2002. Registration certificate NR-348-D-109-B.

16 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

05/17/2002 02-08 Ward 3 Tritium Technologies,

LLC ML Series Request to change the

following certificates to a newvendor number. They are:NR-8126-D-801-E, NR-8126-D-802-E, & NR-8126-D-803-E.To Fees 2/21/2002.Check #503 dtd 2/8/2002 inthe amount of $7700.00 forLicense Application Feereceived.Ret'd from Fees 3/5/2002.Case rejected due to noresponse from licensee.Closed and completed as of5/17/2002.

05/22/2002 02-03 Lee 1 Sensor Applications,

Inc. M90 Chemical Agent Detector

Request for radiation safetyevaluation and registration ofthe Environics ChemicalDetector module.1st reviewer: Seung Lee2nd reviewer: Ujagar BhachuTo Fees 1/14/2002.Def. ltr sent out 2/8/2002 toKen Burbach for the ModelM90. Def. resp. rec'd 2/26/2002. ADAMs #ML020380366.Copies faxed to Mr. Burbachand Mr. Port.2nd def. ltr sent 3/11/2002.Ret'd from Fees 4/1/2002.Closed 5/22/2002. Registration certificate NR-174-D-101-E amended in itsentirety and License 45-25316-03E was amended inits entirety too.

17 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

06/06/2002 02-15 Bhachu

1 Tesoro Hawaii Refinery

13320 Request to deactivateregistration certificate NR-321-D-105-S.1st reviewer: Ujagar Bhachu2nd reviewer: John JankovichTo Fees 3/28/2002.Ret'd from Fees 4/10/2002.Closed out by letter to RossRolirad enclosing inactivatedcertificate NR-321-D-105-S. New certificate number is NR-321-D-801-S. Ujagar to place into ADAMsshortly.

06/06/2002 02-17 Bhachu

3 Department of the Army

GID-3, M43A1, CAM, ICAM

Request to amend NR-1129-D-101-S, NR-1129-D-102-S &NR-1129-D-103-S.To Fees 4/4/2002.1st reviewer: Ujagar Bhachu2nd reviewer: John JankovichRet'd from Fees 4/10/2002.Closed out by letter to PatrickKofalt, amending certificatesNR-1129-D-101-S, NR-1129-D-102-S & NR-1129-D-103-Sto reflect their currentdistribution address.Ujagar to place in ADAMsshortly.

18 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

06/13/2002 02-16 Bhachu

1 Powertronic Systems,Inc.

Drift Tube and Dual Drift Tube

Error found in materialsubmitted by Powertronics toobtain license. Misinformationwas given concerning thesource model number for theirdevice models.To Fees 4/2/2002.This will also require a changeto their E-license as well.Ret'd from Fees 4/10/2002.Closed out 6/13/2002. Amended registrationcertificate NR-1065-D-101-Eto reflect typo in previousversion. Model Numberchanged to read AMM, insteadof AMM.4. Ujagar to place inADAMs later.ADAMs number for NR-1065-D-101-E - ML021650592

19 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

06/17/2002 01-54 Ward 2 MDS Nordion GammaMed 12i/12it &

GammaMed 212 Request for modifications toregistration certificates NR-220-D-121-S & NR-220-S-124-S.Bill Ward - 1st reviewerJohn Jankovich - 2nd reviewerReference SSD Case 01-39(NR-220-D-121-S), SSD Case01-21 for NR-220-S-124-S).To Fees 12/19/2001.Ret'd from Fees 1/22/2002.Closed out 6/17/2002. NR-220-D-221-S corrected pages4, 9 & 10 NR-220-S-124-Scorrected pages 2, 3, 7 & 8.Cover letter - WP versionML021680438Corrected NR-0220-D-121-SML021700346Corrected NR-0220-S-124-SML021700362note to file-why no checklistML021700367Cover letter - scannedw/signaturesML021700372Form 567 -ML021700810incoming letter -ML021700806.

06/25/2002 02-25 Bhachu

1 Yale Security, Inc. 7600X Series Request to amend NR-597-D-101-E. Model numberchange.To Fees 5/17/2002Ret'd from Fees 5/20/2002.Case closed June 25, 2002. Company withdrewamendment request in a letterdated April 29, 2002 for NR-597-D-101-E.

20 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

06/27/2002 01-55 Bhachu

1 Advanced Technical Dual Drift Tube Request for registration forSS&D.Device previously registeredunder NR-1065-D-101-E byPowertronics Systems, Inc. Intellitec will be building thisidentical dual drift tube deviceto print as indicated inapplication.Check #0014749 rec'd in theamount of $1,000.00.1st reviewer: U. Bhachu2nd reviewer: J. JankovichTo Fees 1/2/2002.Ret'd from Fees 3/5/2002.RAI sent out 4/22/2002.2nd RAI sent out 5/31/2002.Closed out 6/27/2002.Package ML021160384.NR-1167-D-101-E(ML021830650).

07/09/2002 02-12 Lee 1 Environics USA, Inc. ChemPro 100 Chemical Detector

Request for evaluation andregistration of ChemProSeries Chemical Detector.1st reviewer: Seung Lee2nd reviewer: Ujagar BhachuTo Fees 3/13/2002.Acceptance review completed3/20/2002. Found to be ok.RAI sent out 3/28/2002.Ret'd from Fees 4/1/2002.Def. ltr sent 5/7/2002.Closed out 7/9/2002 withissuance of new certificateNR-1160-D-101-E(ML021890408).

07/19/2002 02-20 Lee 1 System Sensor 500B ionization chamber

Request to add the 500Bchamber to NR-547-D-101-E.To Fees 4/17/2002.Ret'd from Fees 4/25/2002.Closed 7/19/2002.Completion of Exempt dist.license #12-15023-02-EAmendment #26 & NR-547-D-101-E amended in its entirety. (ML021890051).

21 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

07/22/2002 02-18 Lee 1 Kidde Fenwal CPD-7020, 7021, 7010, 7011,

1201, A-30, A-SO Request to amend devicesheet NR-668-D-101-E.1st reviewer: Seung Lee2nd reviewer: John JankovichTo Fees 4/10/2002.Ret'd from Fees 4/22/2002.Closed 7/22/2002.ADAMs Package#ML0210805217NR-668-D-101-E (amended inits entirety) &License 20-15285-03EAmendment #4.

07/23/2002 02-22 Lee 2 Grinnell Fire Protection OIB, MF Series, Lo-Pro Series

Deactivation of NR-776-D-101-E & NR-776-D-102-E.1st reviewer: Seung Lee2nd reviewer: John JankovichTo Fees 5/2/2002.Def. ltr sent 5/3/2002. ML021230111Ret'd from Fees 5/17/2002.Closed 7/23/2002.Termination of License #34-23772-02-E (ADAMs#ML021990147) & NR-776-D-102-E to inactive status. NewNumber NR-776-D-802-E(ADAMs #ML021960049).

22 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

07/25/2002 02-04 Ward 1 Meprolight ML Series Request to amend NR-1119-

D-101-E.1st reviewer: Bill Ward & JohnJankovich2nd reviewer: Ujagar BhachuTo Fees 1/29/2002.Ret'd from Fees 3/5/2002.Def. ltr sent June 13, 2002. ADAMs #'s ML021640496 &ML021640658.Closed 7/25/2002 due to lackof response. Def. ltr was sent6/13/2002, and Meprolight hasnot responded yet, therefore;we are closing the case outbefore the 180 day deadline. Case will be reopened whenresponse is rec'd.

07/30/2002 02-30 Ashkeboussi

1 AEA Technology QSA,Inc.

Models PS-131 & EZ-202

Req. for new app. of thesmoke det. Models PS-131 &EZ-202. These devices areintended for exempt dist. &separate amdt to R-I will bemade to AEA exempt dist.license #20-12836-02-E forthese devices.1st reviewers: NimaAshkeboussi & UjagarBhachu.2nd reviewer: John JankovichCheck #1589 in the amount of$5,400.00 rec'd.To Fees 7/25/2002.Closed 7/30/2002. Caserejected due to insufficientinformation.Ret'd from Fees 8/7/2002.

23 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

08/13/2002 02-31 Ward 1 Montestino Tech., Inc. Model ISOSINT 2000

Application for importation ofthickness gauge devices fromElectronic Systems, spa, intothe U.S. Devices intended forgeneral license.Check #3048 rec'd in theamount of $5,400.00.1st reviewers: Bill Ward/JohnJankovich2nd reviewers: U. Bhachu/J.JankovichTo Fees 7/30/02.Ret'd from Fees 9/10/2002.

Note for the file: SSD-02-31

Please note that I received aphone call at 2:30 pm, August6, 2002, from Mr. Perry Fan atMontesino (phone: 201 888-6721, e-mail:[email protected]). He is the co-owner of thecompany. He wanted to knowthe status of the application. Itold him that we aredeveloping the deficiencyquestions and we will send thequestions to him as soon asthey are ready.

He also said that theircompany in Delaware will notstore the units. The units willbe shipped directly to theusers. He described the roleof the company in Delawareas "sales agents." We mustfollow up in the reviewregarding their licensing forsuch drop-shipments.

John Jankovich 1st reviewers: John Jankovich& Nima A. (changed from BillWard)2nd reviewer: Seung LeeApplication rejected8/13/2002. Incompletedocuments and unavailabilityof adequate information. ML022250037

24 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

08/20/2002 02-32 Lee 1 Lite Pro Teknolite 3 Requesting amendments to

License #09-23879-01E & NR-1145-D-101-E.1st reviewer: Seung Lee2nd reviewer: John JankovichTo Fees 7/30/2002Ret'd from Fees 8/7/2002.Closed 8/20/2002 by letter toJoe Tchira enclosing License09-23879-01E & amendedcertificate NR-1145-D-101-E.

08/23/2002 02-10 Bhachu

1 IMS Systems, Inc. 5301 tube wall thickness gauge

Application for new device.1st reviewers: Ujagar Bhachu2nd reviewer: John JankovichTo Fees 3/5/2002.Check #2070 in the amount of$5,400 rec'd for applicationfee.Ret'd from Fees 3/8/2002.Closed out by adiscontinuation letter of reviewand evaluation on 8/23/2002.Letter sent out 9/10/2002 toJohn Buckman in response toIMS Systems, Inc. 9/3/2002;stating that IMS be allowed torespond to NRC findings andsupply answers and additionalinformation requested by NRCwithout the need to completelyresubmit the application.

08/30/2002 02-33 Jankovich

1 Trijicon, Inc. Gun sights Request for registration ofmodel TX** series gun sightscontaining 100 mCi of tritiumgas.1st reviewers:J.Jankovich/N.Ashkeboussi2nd reviewer: U. BhachuTo Fees 8/19/2002.Case rejected 8/30/2002; dueto lack of information.Closed out 8/30/2002.

25 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 09/10/2001 to 09/30/2002

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Reviewer

CompanyModel Numbers Status

09/05/2002 02-23 Bhachu

1 MDS Nordion Gammabeam X200

New device registration.1st reviewer: Ujagar Bhachu2nd reviewers: Bill Ward &John JankovichTo Fees 5/3/2002.Ret'd from fees 7/18/2002.Def. ltr sent 8/5/02 (ltr dtd8/2/02) requesting additionalinformation.Case discontinued 9/5/2002for lack of information.Discontinuation letter sent out9/5/2002.ADAMs ML023090361.

Total Completed Case(s) is 55 Totaling 101 Action(s)

26 Materials Safety & Inspection Branch

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Attachment DSection 2 of 4

List of SS&D Cases

Completed between 10/1/2002 - 9/30/2003

(listed in order of completion date)

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Sealed Source & Device ActionsFor Fiscal Year 2003

MSIB-A StatisticsMonth Received Completed Pending

October 11 4 22November 10 3 29December 3 8 24January 28 5 47February 6 2 51

March 15 16 50April 9 4 55May 8 32 31June 67 2 96July 7 4 99

August 1 14 86September 0 63 23

TOTALS 165 157 23

Fee Statistics FeeCategory

Total Actions Requiring Fees Not Requiring Fees

Pending*

Completed Pending* Completed Pending* Completed

9AA 150 142 14 14 136 128

9AN 13 13 9 8 4 5

9BA 0 0 0 0 0 0

9BN 0 0 0 0 0 0

9CA 2 1 0 0 2 1

9CN 0 1 0 1 0 0

9DA 0 0 0 0 0 0

9DN 0 0 0 0 0 0

Totals 165 157 23 23 142 134* Pending Actions under Fee Statistics only includes Fiscal Year data. Materials Safety and InspectionBranch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Reviewer

CompanyModel Numbers Status

10/08/2002 02-24 Bhachu

1 MDS Nordion GammaMed Plus 3/24

Amendment to NR-220-D-122-S to include the GammaMedPlus 3/24.To Fees 5/8/2002.Ret'd from Fees 5/17/2002.Closed out 10/8/2002. MDSNordion requested applicationbe withdrawn in a letter datedSeptember 30, 2002.ADAMs Package Number: ML022740193.

10/11/2002 02-37 Ward 1 21st Century Tech., Inc. CL/1,5/4,85, CL/0,95/3,3

Amendment to NR-365-D-101-E with a different size glasstube.Also, Bruce Carrico will beamending the license part ofthis 42-23850-02E.1st reviewers: Bill Ward &John Jankovich2nd reviewers:SeungLee/John JankovichTo Fees 9/23/2002.Returned from Fees10/7/2002.

10/23/2002 02-21 Ward 1 IMS Systems, Inc. 5245-xxx series - NR-1120-D-

101-S Amendment to model 5245-xxx series for deviceregistration NR-1120-D-101-S.To Fees 4/29/2002.Ret'd from Fees 5/17/2002.Def. ltr sent 8/5/2002 (letterdtd 8/2/02) requestingadditional information.Closed 10/23/2002.NR-1120-D-101-S(ML022960046).

1 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Reviewer

CompanyModel Numbers Status

10/24/2002 02-29 Bhachu

1 Scan Technologies CM100 Monitor

SS&D application for theCM100 Conductive MaterialsMoisture Monitor.Previous case number - 01-37which was discontinued2/22/02 due to lack ofsignificant information.To Fees 6/25/2002.Letter from ScanTech dated7/5/2002 rec'd and placed intoADAMs 7/10/2002. ML021910233Due date changed to10/31/2002 because C. Coxcommitted to this date in theresponse to the congressionalinquiry.Closed 10/24/2002. NR-469-D-101-S (ML022970070)

2 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Reviewer

CompanyModel Numbers Status

11/12/2002 02-28 Jankovich

1 Truglo, Inc. Archery sight pin

Application for both themanufacturer & distributor foruse by the recreationalsportsman involved in thesport of archery to improvelow-light shooting capabilities.Check 009264 in the amountof $9,900.00 dated June 13,2002. This amount is for thess&d application as well astheir materials licenseapplication.1st reviewer: J. Jankovich2nd reviewer: Ujagar BhachuTo fees 6/18/2002.Acceptance review completedand ok 6/25/2002.Acceptance of an affidavitletter sent out 8/7/2002.RAI sent out 9/20/2002.Closed out 11/12/2002, byissuance of registrationcertificate NR-1180-D-101-E &License No. 42-23889-01E.Has not yet been placed intoADAMs. Package has beencreated though to placematerial in and that number is: ML022800089.Certificate: ML023180101.

11/14/2002 03-03 Bhachu

1 21st CenturyTechnologies

Luminous Rifle/Gun Sights

Amendment to NR-365-D-101-E to sell luminous rifle/gunsights to Insight Technology.1st reviewer: Ujagar Bhachu2nd reviewer: John JankovichTo Fees 10/15/2002.Ret'd from Fees 10/30/2002.RAI sent 11/4/2002.Closed out 11/14/2002.Amendment 4 of License 42-23850-02E was issued11/14/2002.Request for withholding lettersent out 12/20/2002.

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3 Materials Safety & Inspection Branch

Closed Sealed Source & Device Actions

By Date Completed for the period 10/01/2002 to 09/30/2003For actions recorded as of Tuesday, July 26, 2005

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Reviewer

CompanyModel Numbers Status

11/25/2002 02-26 Bhachu

1 MDS Nordion C-378 Amendment to add Model C-378 to registration certificateNR-220-D-102-S.To Fees 5/30/2002.1st reviewer: Ujagar Bhachu2nd reviewer: John JankovichRAI sent 8/20/2002.Def. resp. rec'd 9/18/2002.Closed out 11/25/2002. Issued registration certificateNR-220-D-102-S which wasamended in its entirety. Ujagar to add to ADAMs upondistribution.

12/04/2002 03-08 Ashkeboussi

1 U.S. EPA Fixed Moisture Density Gauge

Request to deactivate NR-162-D-101-S.1st reviewers: Ashkeboussi/Jankovich2nd reviewer: BhachuTo Fees 11/21/2002.Vendor number "8132" hasbeen assigned for theinactivation.Case closed 12/4/2002. Certificate inactivated. Newnumber: NR-8132-D-801-S. This supercedes NR-162-D-101-S. ADAMs AccessionNumber: ML023430060.

4 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Reviewer

CompanyModel Numbers Status

12/04/2002 03-10 Rivera 5 Trilux Technologies, Inc. FB, FBW, FP, RBW, RHP, RLP,

& SG Series Request to amend NR-1028-D-101-E to add 5 additionalgun/bow sight designs.1st reviewers: JonathanRivera 2nd reviewer: John JankovichTo Fees 11/27/2002.Will also be amending the E-license 32-23774-02E(Amendment 4).Ret'd from Fees 12/18/2002.Case discontinued 12/4/2002per conference call withJonathan Rivera and JohnJankovich.The letter was sent out12/9/2002 and is under thepackage ML023430195.

12/06/2002 02-27 Ward 1 Savage Systems, Inc. archery sight pins

application for materialslicense & distribution ofarchery sight pins.Check 6909 for $3400 sent in,however; they should've sent$5400.1st reviewer: Bill Ward/JohnJankovich2nd reviewer: Seung LeeTo Fees 6/14/2002.Acceptance review completed6/24/2002.Ret'd from Fees 7/8/2002.Closed out 12/6/2002 by letterto Hugh Savage along with anew registration certificate NR-1183-D-101-E. Bruce Carricoto start working on E-license.

5 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Reviewer

CompanyModel Numbers Status

12/30/2002 03-11 Ashkeboussi

1 HemisphereForwarding, Inc

1001, EL100BUS, LUS, & SUS

Request to deactivate NR-1040-D-101-E.1st reviewers: Nima and JohnJ.2nd reviewer: UjagarTo Fees 12/2/2002.Tony Kirkwood will do theamendment to the license 31-23829-01E.RAI lettr sent out 12/9/2002.Closed 12/30/2002 by letter toMichael Avnet enclosinginactivation of certificate NR-1040-D-101-E to NR-8133-D-801-E. ADAMs PackageML023640215.Returned from Fees4/15/2003.

01/08/2003 03-05 Rivera 1 Perkin Elmer NR-536-D-109-B-L413-

0127,&28,N600-0030 &113 Request for deactivation ofNR-536-D-109-B.1st reviewers: Rivera/Bhachu2nd reviewer: JankovichTo Fees 10/17/2002.Ret'd from Fees 10/30/2002.Def. ltr sent out 11/6/2002. Package Number: ML023090438.Closed out January 8, 2003 byletter to Mr. John Widomskiinactivating registrationcertificate NR-536-D-109-B. The new registration numberis NR-536-D-808-B.ADAMs package numberML023090438.

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CompanyModel Numbers Status

01/14/2003 03-09 Ashkeboussi

3 Best Industries 81-01, 81-02, 2300 series seeds

Name change for NR-187-S-101-S, NR-187-S-102-S, NR-187-S-103-S. This is a namechange only!1st reviewers: Ashkeboussi/Jankovich2nd reviewer: BhachuTo Fees 11/27/2002.Ret'd from Fees 12/18/2002.Closed out January 14, 2003by amending in their entirety,certificates:NR-187-S-101-S, NR-187-S-102-S, NR-187-S-103-S.To be placed into ADAMsshortly.

7 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

01/21/2003 02-35 Ashkeboussi

1 AEA Technology PS-131 & EZ-202

Resubmittal for deviceapproval of the smokedetector Models PS-131 & EZ-202.These devices are intendedfor exempt distribution andseparate amendment toRegion I will be made to AEATechnology QSA, Inc.'s USNRC exempt distributionlicense number 20-12836-02-E.Previously discontinued (SSD02-30). Fee was paid in SSD02-30.1st reviewers: Ashkeboussi/Jankovich2nd reviewer: Ujagar BhachuTo Fees 9/10/2002.Request for withholdinginformation from publicdisclosure letter sent out9/12/2002. AEA to submitanother affidavit stating needfor withholding.Returned from Fees10/7/2002.Affidavit sent out 10/10/2002.RAI sent out 11/7/2002. SSD team finished case 02-35on January 21,2003 andtransfered it to licensing onthat date. Bruce Carrico hasfolder.The SS&D part of this case isfinished. Bruce Carrico is stilllooking at the amendment tothe E-license.

02/05/2003 03-04 Jankovich

1 Smiths Detection IonScan 100, 200, 250, 350, 400,Sabre 2000

Name & Label change to NR-163-D-101-G.1st reviewers: Jankovich &Nima A.2nd reviewer: Ujagar BhachuTo Fees 10-16-2002.Ret'd from Fees 10/30/2002.Def. ltr sent 11/27/2002.Closed 2/5/2003.NR-163-D-101-G wasamended to show change -certificate dated 2/4/2003.

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CompanyModel Numbers Status

02/24/2003 02-34 Ward 1 Meprolight Various (e.g., ML-100, ML-1150,

ML-750 Please reference SSD Case02-04 which was discontinuedJuly 25, 2002; due to noresponse to deficiency letter.Request to amend NR-1119-D-101-E to add various modelnumbers to their devices.1st reviewers: Bill Ward &John Jankovich2nd reviewer: Ujagar BhachuTo Fees 8/28/2002.This is a device amendment.Ret'd from Fees 9/10/2002.Closed 2/24/2003. Issuanceof NR-1119-D-101-E amendedin its entirety. License 08-23873-01-E Amendment 1issued as well.

03/06/2003 03-13 Rivera 1 United Technologies

Corp. PFG-1 Request to inactivate

registration certificate NR-655-D-103-S.1st reviewers: JonathanRivera & John Jankovich2nd reviewer: Ujagar BhachuTo Fees 12/4/2002.Ret'd from Fees 12/18/2002.Letter sent out to GlennJanowsky issuing inactivatedcertificate number NR-655-D-802-S. Sent to DocumentProcessing Center 3/6/2003for scanning into ADAMs.

9 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

03/17/2003 03-21 Ashkeboussi

1 Environics Chempro 100

Amendment to NR-1160-D-101-E.1st reviewers: Nima A. &John Jankovich2nd reviewer: Ujagar BhachuTo Fees 3/6/2003Closed 3/172003. Registration certificate NR-1160-D-101-E amended in itsentirety.Nima to place into ADAMs.Returned from Fees4/15/2003.R. Struckmeyer sent out letteron June 4, 2003.

03/18/2003 03-15 Kime 1 General Dynamics Dual Drift Tube Name Change Only!!!

1st reviewers: Kime &Jankovich2nd reviewer: Ujagar BhachuTo Fees 1/28/2003.Ret'd from Fees 3/7/2003.Closed out March 18, 2003. NR-1167-D-101-E wasamended in its entirety.Package number: ML030770581

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CompanyModel Numbers Status

03/18/2003 03-12 Rivera 1 Lite Pro Teknolite 2, 3, & 4

Request to amend NRCRegistration Certificate NR-1145-D-101-E to add minormodifications/updates to SSDLot Testing Procedure. Wewill also be modifying our Elicense as well - 09-23879-01E.1st reviewers: JonathanRivera and John Jankovich2nd reviewer: Ujagar BhachuTo Fees 12/3/2002.Ret'd from Fees 12/18/2002.Closed out 3/18/2003. NR-1145-D-101-E was amendedin its entirety.Package number: ML030760292Jonthan Rivera spoke withTony Kirkwood on March 20,2003; regarding the E-licensepart of this. Tony Kirkwood completedLicense March 21, 2003. (ML030210127)

03/19/2003 03-06 Rivera 3 Smiths Detection Sabre Centurion, Ionscan

Sentinel II Request to add two newproducts to existingregistration NR-163-D-101-G.1st reviewer: Jonathan Rivera2nd reviewer: John JankovichTo Fees 10/17/2002.Ret'd from Fees 10/30/2002.Case rejected 3/19/2003 dueto incomplete documentation.

11 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

03/20/2003 03-02 Jankovich

4 447 March Road MDS Nordion

Request for inactivation of thefollowing:NR-220-D-121-S, NR-220-D-122-S,NR-220-S-123-S, NR-220-S-124-S.Two source amendments &two device amendments.Sent in a letter dated9/30/2002. Rec'd letter by fax10/8/2002.1st reviewer: John Jankovich2nd reviewer: Ujagar BhachuTo Fees 10/8/2002.Ret'd from Fees 10/30/2002.Def. ltr sent out 12/2/2002.Case discontinued 3/20/2003due to insufficientdocumentation.Nima Ashkeboussi to place inADAMs.

03/26/2003 02-05 Ward 1 MDS Nordion C-168 Deficiency response to

November 20, 01 e-mail.Previous case number 01-29.To Fees 2/7/2002.Ret'd from Fees 4/1/2002.Def. ltr sent 8/5/02 (ltr dtd8/2/02) requesting clarificationof info in application for C-168source. Bill sent a copy of ltrvia e-mail on 8/2/02.Closed out 3/26/2003 by letterand issuance of NR-0220-S-125-S.Bill Ward to place in ADAMsupon his return the week ofApril 7, 2003.

12 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

03/27/2003 02-36 Bhachu

1 IMS Systems, Inc. 5301, 5301-1 tube wall thicknessgauges

Safety Review of the IMSModels 5301 & 5301-1 TubeWall Thickness Gauges.No new fee is neededbecause this is a follow-up toSSD 02-10 that wediscontinued 8/23/2002.1st reviewers: Ujagar Bhachu2nd reviewer: John JankovichTo Fees 9/19/2002.Closed 3/27/2003. Issued NR-1120-D-104-S

03/27/2003 03-27 Tiktinsky 2 Meprolight, Inc. ML-100, 1150, 442 thru 444

series Amendment to registrationcertificates NR-1119-D-101-E& NR-1119-D-102-E to showchange of address.They also need to amend theirE-license to show change ofaddress as well. LicenseNumber: 08-23873-01E.1st reviewers: Dave Tiktinsky& Ujagar2nd reviewer: John JankovichTo Fees 3/27/2003.Cancelled: No SSD actionneeded, E-license action only.

13 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

03/31/2003 03-01 Ashkeboussi

1 Trijicon, Inc. Gunsight Models TX** series

Continuation of SSD 02-33which we rejected August 30,2002.1st reviewers: Nima A. &John J.2nd reviewer: UjagarBhachuTo Fees 10/3/2002.Fee paid August 8, 2002 for$2300.00.Check #45044.Ret'd from Fees 10/30/2002.Def. ltr sent out 2/27/2003requesting better clarificationof information requested.Closed out 3/31/2003 byissuance of amendedcertificate number NR-0418-D-101-E.Request for withholdinginformation from publicdisclosure, Trijicon, Inc. Tx xxSeries Gun Sights -4/17/2003.

04/01/2003 03-19 Jankovich

1 Unertl OpticalCompany, In

Gun Sights Application for material licensefor gun sights containingtritium gas sealed in sealedglass vials.TAC Number: L208891st reviewer: John Jankovich2nd reviewer: Ujagar BhachuTo Fees 2/27/2003.Bruce Carrico is doing the E-license part of this case.Discontinued 4/1/2003. Insufficient information inapplication.Package: ML030920139

14 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

04/02/2003 03-07 Jankovich

1 MDS Nordion Gammabeam X200

Reapplication of the MDSNordion request to obtain adevice registration for theGammabeam X200 GammaIrradiator.No fee is needed. This is thecontinuation of 02-23 whichwas discontinued 9/5/2002.1st reviewer: John Jankovich2nd reviewer: Ujagar BhachuTo Fees 11/4/2002.Ret'd from Fees 12/18/2002.Letter re: request forwithholding sent out 3/4/2003. ML030430044Closed out April 2, 2003 byissuance of NR-0220-D-128-Sfor Gammabeam X200irradiator.Will place into ADAMs4/3/2003.

15 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

04/15/2003 03-24 Kime 1 System Sensor 1000K, 500A, 500B, 700A Series

Merger of Pittway Corporationinto Honeywell International,Inc. Amend NR-547-D-101-Eand License 12-15023-02E1st reviewers:TKime &JJankovich2nd reviewer:UBhachuTo Fees 3/13/2003.E-mail sent to Jim Stach3/19/2003 [email protected] the following e-mail. "Weare in the process ofamending your RegistrationCertificate NR-0547-D-101-Efor your smoke detectorproducts in response to yourletter dated February 10,2003. Currently, theRegistration Certificate showsfour locations formanufacturing: St. Charles,IL, Mexico, China, and Italy. Each of these facilities havethe "System Sensor"designation in their names. Please provide the exactname and address of yourmanufactures as it will appearafter the merger intoHoneywell International, Inc."Closed April 15, 2003. Amended registrationcertificate NR-547-D-101-E.Given to Ujagar for signature4/15/03.Given to Tony Kirkwood4/15/2003, for the E-licensepart of the case.E-license closed out3/10/2003.Package ML030780117 (ssdpart).

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CompanyModel Numbers Status

04/17/2003 03-20 Ashkeboussi

1 Scan Technologies CM100 Coke Moisture Gauge

Request to amend NR-469-D-101-S to specify range ofmeasurement gaps of 400mm.1st reviewers: Nima & Ujagar2nd reviewer: John JankovichTo Fees 3/4/2003.Returned from Fees4/15/2003.Closed out 4/17/2003. Correction to registrationcertificate NR-0469-D-101-Sto Page 2 and Attachment 1.ADAMs PackageNumber:ML031080073

17 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

05/05/2003 01-53 Jankovich

1 Air Products & Controls Series 60A, Series XP95A, TP90

Request to add devices to theApollo/Air Products & ControlsLicneses.E-License - 21-23805-02ERegistration - NR-160-D-101-E.1st reviewers: John Jankovich2nd reviewer: Ujagar BhachuJonathan Rivera to assistreviewers.To Fees 12/19/2001.Ret'd from Fees 1/22/2002.Def. ltr sent 11/27/2002.

Note for the Record:I received a telephone calltoday, January 10, 2003, from Dr.Robert Dudley, Apollo/AirProducts Systems, in England. He said that they havereceived NRC's deficiencyletter, dated November 27,2002, today only. Consequently, he is not ableto respond to the questionswithin 30 days from the date ofthe NRC letter, as requested.SS&D part of this case wasclosed out on May 5, 2003.

I told him that the delay inreceiving the letter must havebeen due to the NRC mailroom not sending it by air mailto the overseas address. Itold him that we will notterminate the case due to lateresponse. Dr. Dudleyindicated that Apollo/AirProducts Systems will be ableto respond to the questions inabout 10 days. John Jankovich

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CompanyModel Numbers Status

05/19/2003 03-16 Ashkeboussi

1 Canberra Industries,Inc.

NRC-D-701049

Request to inactivate NR-504-D-117-S.1st reviewers: Nima A. &John Jankovich2nd reviewer: Ujagar BhachuTo Fees 2/25/2003.Technical Assignment ControlNumber: L20888 (Goes thru MarilynMoore).Ret'd from Fees 3/7/2003.Closed 5/19/2003 by letter toMs. Edwina Milicicacknowledging cancellation oftransfer of device certificatesof registration from Aptec-NRC/Canberra to BertholdSystems, Inc.ML031280720

05/19/2003 01-56 Ward 2 BSI Instruments SH-300 Series &LS-101

Change in registration ofGammatrol Sources & Shieldsfor registry numbers NR-504-D-111-B & NR-504-D-109-B.1st reviewers: Bill Ward & J.Jankovich2nd reviewer: U. BhachuTo Fees 1/2/2002.RAI sent 7/25/2002.Reply to deficiency letters for01-56 received. Case shouldbe issued soon per Bill Ward8/29/2002.Closed 5/19/2003 byinactivation of Aptec-NRC/Canberra DeviceCertificates of RegistrationCertificate Numbers NR-504-D-109-B, NR-504-D-111-B &NR-504-D-117-S.

New inactive certificatenumbers are:NR-504-D-814-B-replaces NR-504-D-109-BNR-504-D-815-B-replaces NR-504-D-111-BNR-504-D-816-S-replaces NR-504-D-117-S

19 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

05/27/2003 03-14 Ashkeboussi

27 Safety Light Corporation Various Request to amend NR-579-D-112-G to add a series ofnumbers which have beenmanufactured and distributedby Self Power Lighting for useon aircraft per 10CFR31.7.1st reviewers: N.Ashkeboussi/U.Bhachu2nd reviewer: John JankovichTo Fees 1/28/2003.Deficiency letter sent out2/12/2003. 1. Proprietary designation2. Drawings for device series3. Quality Assurance4. Source Technical DataRet'd from Fees 3/7/2003.Closed out 5/27/2003 by letterto Larry Harmon enclosingamended certificate NR-0579-D-112-G for Safety LightCorporation. Dispatched on5/28/2003.Nima Ashkeboussi to finishplacing in ADAMs upondistribution.tk

05/27/2003 03-28 Jankovich

1 Cammenga &Associates, Inc

13208E4680

Request to amend NR-210-D-101-E.Cammenga will also berenewing their E-license 21-26460-02E.1st reviewer: John Jankovich2nd reviewer: Ujagar BhachuTo Fees 4/3/2003.Returned from Fees4/15/2003.Response rec'd from licenseeto RAI by e-mail 4/10/2003.SSD part of this casecompleted 5/27/2003. E-license action to this wasgiven to Binesh Tharakan5/27/2003. We'll send out ajoint cover letter for both whenlicense reviewer is finished.RAI sent out 7/11/2003 by A.Kirkwood.

20 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

06/04/2003 03-31 Bhachu

1 Molins Richmond, Inc. Cigarette Density Gauge

This is a new case forreactivation and also anamendment to reinstateregistration certificate NR-462-D-803-B.Check number 115835 rec'd4/9/2003 in the amount of$5,600.00.Check sent to Karen Butler.1st reviewers: U. Bhachu, D.Tiktinsky2nd reviewer: J. JankovichTo Fees 4/15/2003.TAC Number: L20891.Returned from Fees 5/8/2003.Returned from Fees 5/8/2003.Discontinued 6/4/2003. Molinswill have to send in anapplication to amend NR-462-D-803-B instead of areactivation as previouslyrequested by Molins.

06/04/2003 03-25 Jankovich

1 Environics Chempro 100

Request to amend NR-1160-D-101-E to add Environicsnew facility in Florida.1st reviewer: John Jankovich2nd reviewer: Ujagar BhachuPlease reference SSD Case03-21. E-license also needs changing(45-23885-02E).To Fees 3/25/2003.Returned from Fees4/15/2003.Case discontinued June 4,2003.Letter sent out June 4, 2003;from Rich Struckmeyer.

07/02/2003 03-30 Kime 1 MDS Nordion C-133 Name Change on Sealed

Source Registration NR-169-S-124-U.1st reviewers: T. Kime, J.Jankovich2nd reviewer: U. BhachuTo Fees 4/15/2003RAI sent by e-mail 4/21/2003.Package ML031190259

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CompanyModel Numbers Status

07/03/2003 03-29 Tiktinsky 1 iTi Qualitek, Inc. Leakmeter 120, Q200 Leakmeter

Amendment to NR-1128-D-101-E to show companyownership change & location. iTi will also be amending theirE-license 20-15525-02E.1st reviewers: David Tiktinsky JohnJankovich2nd reviewer: Ujagar BhachuTo Fees 4/3/2003.Returned from Fees4/15/2003.Def. ltr sent 5/5/2003.RAI sent out 6/10/2003.Rich Struckmeyer doing E-license amdt.SS&D part closed out on7/3/2003. ADAMs PackageML030940635.SSD folder given to RichStruckmeyer on 7/11/2003, forhis completion of the E-license.

07/17/2003 03-35 Tiktinsky 1 Perkin Elmer Voyager Request to inactivate NR-536-

D-110-B.1st reviewers: Tiktinsky &Jankovich2nd reviewer: BhachuTo Fees 5/13/2003.Ret'd from Fees 5/27/2003.Closed out July 17, 2003 byletter to J.Widomski andamended certificate NR-536-D-110-B. ADAMs PackageNumber: ML031970085

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CompanyModel Numbers Status

07/21/2003 02-01 Bhachu

1 Integrated Industrial RSS-12 Application to manufacture aGL sealed source thicknessmeasuring device.Application is in ADAMs(ML020150287)Fee attached in the amount of$2,200.00 (Check #201750).Ujagar Bhachu 1st reviewerJohn Jankovich 2nd reviewer.Jonathan Rivera to assistreviewers.To Fees 1/10/2002.Ret'd from Fees 3/5/2002.Deficiency letter sent out3/6/2003.RAI sent on 4/3/03.Response received on 5/9/03.Case completed July 21,2003, by letter to RandyStevens enclosing new devicesheet NR-396-D-102-BIntegrated Industrial Systems.ADAMs Package#ML030620781.

08/01/2003 03-17 Bhachu

2 Met One Instruments E-BAM Request to modify NR-1124-D-101-E & NR-1124-D-102-Eto add a second supplier forthe sealed source used in theirbeta attenuation monitor.1st reviewer: Ujagar Bhachu2nd reviewer: John JankovichTo Fees 2/25/2003.Ret'd from Fees 3/7/2003.Def. ltr sent out 6/13/2003. ML031670172Closed 8/1/2003. Case wasdiscontinued.

23 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

08/05/2003 03-48 Kime 1 Invensys Climate

Controls 120 V/AC Series & 9.0 V Series

Request for name andaddress change to registrationcertificate NR-545-D-101-E. E-license already amended7/9/2003. ADAMs PackageNumber:ML031880243.1st reviewers:T. Kime/J.Jankovich2nd reviewer: U. BhachuTo Fees 7/21/2003.Case completed August 5,2003 by letter to Tom Barakatof Invensys and amendedregistration certificate NR-545-D-101-E.Certificate: ML032180214Letter: ML032180231Returned from Fees8/21/2003.

08/08/2003 03-34 Bhachu

1 Berthold Systems, Inc. LB 300L Level MeasuringDevices

Re-activation of Registrationfor LB 300L Level MeasuringDevice, formerly NR-186-D-106-B, NR-112-D-106-B, NR-8050-D-806-B.1st reviewer: Ujagar Bhachu2nd reviewer: John JankovichTo Fees 4/24/2003.Returned from Fees 5/8/2003.Def. ltr sent 8/8/2003. ML032200450.Closed out 8/8/2003.

08/14/2003 03-32 Tiktinsky 1 Schlumberger H-245258 (NSR-M)

Request to deactivate NR-524-S-104-S.1st reviewers: D. Tiktinsky, U.Bhachu2nd reviewer: John JankovichTo Fees 4/17/2003.Returned from Fees 5/8/2003.Deficiency letter sent5/29/2003. ADAMs Case was discontinued onAugust 14, 2003. Licenseedid not respond with 30 daytimeframe on def. ltr of5/29/2003.Package Number: ML031490323.

24 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Date Completed

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CompanyModel Numbers Status

08/14/2003 03-22 Tiktinsky 7 Ion Track

Instruments,Inc.97, 97A/Vixen Amendment request for

registration certificate NR-399-D-102-E to add 6 new devices. Also, amending their license20-15525-02E1st reviewers: Dave Tiktinskyand John Jankovich2nd reviewer: Ujagar BhachuTo Fees 3/12/2003.Returned from Fees4/15/2003.RAI sent out 6/16/2003. ML031670098.Summary memo to M. Baileyof 7/30/03 meeting with IonTrack on NR-399-D-101-E. ML032300117

08/25/2003 03-18 Ward 2 Drax Image LS-1, PD-103, PD-1

Amendment to NR-1121-S-101-S & NR-1121-S-102-S.1st reviewers: Bill Ward &John J.2nd reviewer: Ujagar BhachuTo Fees 2/25/2003.Ret'd from Fees 3/7/2003.Case closed August 25, 2003,with the issuance of Amendedcertificate NR-1121-S-101-S(ML032340740) andtermination of NR-1121-S-102-S and new issuance ofinactivated certificate NR-1121-S-801-S (ML032340181)which supercedes the 102certificate.

25 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Reviewer

CompanyModel Numbers Status

09/05/2003 03-50 Yin 1 SAIC Small CAD (Chemical Agent

Detector) Application for new ssd reviewfor SAIC'sSmall CAD (Chemical AgentDetector).1st rev's: Xianosong Yin/J.Jankovich2nd rev: Ujagar BhachuCheck Number 0001215170rec'd in the amount of$8000.00. Check dtd8/4/2003.This case will also involve anew E-license distribution aswell.ADAMs Package Number forSSD: ML032340079To Fees 8/22/2003.Xiaosong Yin will also bedoing the E-license review aswell.Docket No.: 030-36398Mail Control No.: 022337Licensing Due Date: 11/24/2003.Case discontinued 9/5/2003due to lack of informationprovided in application. Letterin ADAMs ML032481204Ret'd from Fees 1/7/2004.TAC Number L20896.

26 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Reviewer

CompanyModel Numbers Status

09/08/2003 03-23 Tiktinsky 1 Montesino

Technologies,IncISOSINT 2000

Request registration of ModelISOSINT 2000 ElectronicSystems spa thickness gauge.1st reviewers: Dave Tiktinsky& John J.2nd reviewer: Ujagar BhachuTo Fees 3/13/2003.RAI sent out 4/22/2003.We have received theirresponse. There are fewsmall items that I am nothappy with and will needadditional info from them. Ihave been working on writingup the registration and plan ondiscussing the case with youshortly per Dave Tiktinsky. 6/4/2003.RAI sent out 5/15/2003.TAC Number: L20890Closed out 9/8/2003 with theissuance of NR-1193-D-101-G. ADAMs Package#ML031130015.

09/09/2003 03-26 Tiktinsky 1 Smiths Detection IonScan Request to add new IONScan

models for distribution on NR-163-D-101-G.This references SSD cases03-04 & 03-06.1st reviewers: D. Tiktinsky/U.Bhachu2nd reviewer: J. JankovichTo Fees 3/26/2003.Returned from Fees4/15/2003.RAI sent out 6/16/2003. Case closed 9/9/2003 with theissuance of amendedregistration certificate NR-163-D-101-G.

27 Materials Safety & Inspection Branch

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Closed Sealed Source & Device Actions

By Date Completed for the period 10/01/2002 to 09/30/2003For actions recorded as of Tuesday, July 26, 2005

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CompanyModel Numbers Status

09/11/2003 03-40 Ashkeboussi

56 MDS Nordion Various Inactivation of vendor #169and transfer to vendor #220.1st reviewers: N imaAshkeboussi & JohnJankovich2nd reviewer: Ujagar BhachuTo Fees 6/10/2003.Ret'd from Fees 7/15/2003.Case closed 9/11/2003. Certificates issued: NR-8135-D-806-S thru NR-8135-D-828-S. These certificates weresuperceded by NR-169-D-802-U thru NR-169-D-826-S. Alsoissued were certificates NR-220-D-805-S thru NR-220-D-831-S. These certificateswere also superceded by the169 certificates listed above. ADAMs Package NumberML031960283.

28 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2002 to 09/30/2003

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Date Completed

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Reviewer

CompanyModel Numbers Status

09/11/2003 03-39 Kime 4 MDS Nordion C-11, C-174, Gammacell 220, C-

324/C-236 Name change only for:NR-169-D-103-U, NR-169-D-114-U, NR-169-D-119-U, & NR-169-D-157-S.1st reviewers: T. Kime & J.Jankovich2nd reviewer: Ujagar BhachuTo Fees 6/10/2003.Ret'd from Fees 7/15/2003.Closed out 9/11/2003Certificates issued:NR-8135-D-801-S(superceded NR-169-D-103-U), NR-8135-S-802-S(superceded NR-169-S-114-U), NR-8135-S-803-S(superceded NR-169-S-124-U), NR-8135-D-804-S(superceded NR-169-D-119-U)& NR-8135-S-805-S(superceded NR-169-S-157-S). ADAMs package numberML031671400.

Total Completed Case(s) is 52 Totaling 157 Action(s)

29 Materials Safety & Inspection Branch

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Attachment DSection 3 of 4

List of SS&D Cases

Completed between 10/1/2003 - 9/30/2004

(listed in order of completion date)

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Sealed Source & Device ActionsFor Fiscal Year 2004

MSIB-A StatisticsMonth Received Completed Pending

October 8 3 28November 3 11 20December 15 7 28January 1 5 24February 26 5 45

March 24 21 48April 6 6 48May 9 10 47June 7 15 39July 3 13 29

August 3 23 9September 4 1 12

TOTALS 109 120 12

Fee Statistics FeeCategory

Total Actions Requiring Fees Not Requiring Fees

Pending*

Completed Pending* Completed Pending* Completed

9AA 64 73 4 7 60 66

9AN 14 16 14 16 0 0

9BA 04 0 0 0 0 0

9BN 0 0 0 0 0 0

9CA 30 31 0 0 30 31

9CN 0 0 0 0 0 0

9DA 0 0 0 0 0 0

9DN 1 0 1 0 0 0

Totals 109 120 19 23 90 97* Pending Actions under Fee Statistics only includes Fiscal Year data. Materials Safety and InspectionBranch

Closed Sealed Source & Device Actions

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By Date Completed for the period 10/01/2003 to 09/30/2004For actions recorded as of Tuesday, July 26, 2005

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Reviewer

CompanyModel Numbers Status

10/20/2003 03-33 Bhachu

3 Berthold Systems LB 7400, D&F, NW-201, 301,401

Name Change to registrationcertificates NR-112-D-102-B,NR-112-D-106-B & NR-186-D-117-B.1st reviewer: Ujagar Bhachu2nd reviewer: John JankovichTo Fees 4/24/2003.Returned from Fees 5/8/2003.Letter signed out for add'lquestion and change ofcorporate name dated August19, 2003. ML032300055.Closed 10/20/2003 byissuance of NR-112-D-104-B. NR-112-D-102-B & NR-112-D-103-B to be inactivated undera new case and not amendedper e-mail from Edwina Milicicdated 10/20/2003.

11/04/2003 03-38 Tiktinsky 2 Savage Systems, Inc. Night Hawk 1 & 2

Request to amend NR-1183-D-101-E and to update theirprevious request for an E-license.1st reviewers: D.Tiktinsky &J.Jankovich2nd reviewer: U. BhachuTo Fees 5/29/2003.Bruce Carrico is the licensereviewer in this case.TAC #L20893Ret'd from Fees 7/15/2003.Closed 11/4/2003. Case hasbeen VOID effective11/4/2003. ADAMs packagenumber: ML031960235

1 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

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Reviewer

CompanyModel Numbers Status

11/07/2003 04-05 Herrera 1 MedStar Health GammaMed II

Request to inactivateregistration certificate NR-453-D-101-S.1st reviewers: Tomas Herrera

JohnJankovich2nd reviewer: UjagarBhachuTo Fees 10/9/2003.Closed 11/7/2003 by issuanceof inactivated certificate NR-453-D-803-S.ADAMs Package No.:ML032820332Ret'd from Fees 1/7/2004.

11/12/2003 03-37 Stambaugh

1 Truglo TG131/231 Series

Request to amend NR-1180-D-101-E to add additionalsimilar "aiming sights" to thealready existing license. They've also requested us toamend their E-license as well. 42-23889-01E.1st reviewers: MargaretStambaugh & Ujagar Bhachu2nd reviewer: John JankovichTo Fees 5/27/2003.License reviewer: RichStruckmeyerPackage: ML031540613Ret'd from Fees 7/15/2003.RAI sent out 8/27/2003(ML032390240).Closed out by amendment ofNR-1180-D-101-E 11/12/2003.Package: ML032120274 (E-license)Package: ML031540613(ss&d)

2 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

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Reviewer

CompanyModel Numbers Status

11/14/2003 03-36 Ashkeboussi

4 Drager Safety, Inc. 5000, 5100, 5600, 5700

Application for new SS&D.New E-license will also beneeded.1streviewers:N.Ashkeboussi/J.Jankovich2nd reviewer: U. BhachuCheck #023563 sent in theamount of $5,600.00 for newssd.Check sent to lock box5/21/2003.To Fees 5/27/2003.License reviewer: TonyKirkwoodTAC Number: L20892Package: ML031540604Ret'd from Fees 7/15/2003.Def. ltr sent out 8/22/2003. Letter dated 8/11/2003 toVictor Hoang.Closed out 11/14/2003 byissuance of certificate NR-1199-D-101-E.ADAMs Package: ML031540604

11/14/2003 04-03 Kime 1 Smith's Detection Ionscan 100, 200, 250, 350, 400,

Sabre 2000 Amendment to registrationcertificate NR-163-D-101-G tochange distribution siteaddress.1st reviewer: Traci Kime/JohnJankovich2nd reviewer: Ujagar BhachuTo Fees 10/3/2003.Letter and Certificate given toJohn Jankovich October 8,2003.Closed out 11/14/2003 byletter and amended certificateNR-163-D-101-G.Certificate: ML033180224Letter: ML033180230Ret'd from Fees 1/7/2004.

3 Materials Safety & Inspection Branch

Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

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For actions recorded as of Tuesday, July 26, 2005

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Reviewer

CompanyModel Numbers Status

11/17/2003 03-43 Herrera 1 MDS Nordion C-337A Amendment to NR-220-S-112-

S to allow the use of thesource assembly in theSentinel 880 family ofexposure devices.1st reviewers: David Tiktinsky UjagarBhachu2nd reviewer: John JankovichTo Fees 6/16/2003.Ret'd from Fees 7/15/2003.RAI sent 9/9/2003. ML032530469Def. resp. rec'd via fax10/8/2003.Closed out November 17,2003 by letter to Marc-AndreCharettT from Tomas Herreraenclosing amended certificateNR-220-S-112-S. Package:ML031690319.

11/24/2003 03-45 Herrera 1 Unertl Optical Co., Inc. Gun Sights Application for Distribution of

Exempt Products.1st reviewer: Dave Tiktinskyand John Jankovich, 2ndreviewer: Ujagar BhachuTo Fees 6/27/2003.There is also an E-licenseapplication tied to this as well.TAC Number: L20895Returned from Fees8/21/2003.RAI sent out on August 27,2003. Letter is in ADAMs andML number is: ML032390046.Def. resp. rec'd 10/1/2003.Def. resp. rec'd 10/14/2003.Vendor Number 1200assigned to this case.This is to let you know thatSSD Case No. 03-45 hasbeen completed and thecertificate has been signed asof 11/20/03. I will pass the fileand its contents to Bruce forthe E-Licensing review.

4 Materials Safety & Inspection Branch

Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

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Date

Completed

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Reviewer

Company

Model Numbers Status

12/01/2003 03-41 Kirkwood

1 MTI Industries, Inc. Smoke Detectors

Application for device reviewfor MTI Industries, Inc. todistribute smoke detectors thatare manufactured in HongKong.Check #23238 paid in theamount of $5700 for devicereview.They are also seeking anexempt distribution license aswell.Check #23237 paid in theamount of $2400 for licensereview.Both checks sent to lock box6/10/2003.1st reviewers: Tony Kirkwood& John Jankovich2nd reviewer: Ujagar BhachuTo Fees 6/11/2003.TAC #L20894Returned from Fees8/21/2003.RAI sent out 11/14/2003 to Mr.Widomski. Case voided12/1/2003. ML033350415.

12/02/2003 04-02 Yin 1 Environics ChemPro 100

Amendement to registrationcertificate NR-1160-D-101-Eto reflect some devicechanges. They will also beamending their E-license aswell.1st reviewers: Xiaosong Yinand John J. 2nd reviewer: Ujagar BhachuTo Fees 10/3/2003.SSD Case due: 3/28/2004.License due: 12/30/2003.Xiaosong Yin assigned bothlicense & ssdCase closed out 12/2/2003 byletter to Michael Phillips alongwith amendment certificateNR-1160-D-101-E.Package: ML032760254Ret'd from Fees 1/7/2004.

5 Materials Safety & Inspection Branch

Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

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Date Completed

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Reviewer

CompanyModel Numbers Status

12/04/2003 03-42 Rivera 1 Hermes Abrasives, Ltd.

TIAM 11 Request to inactivate NR-394-

D-102-S.1st reviewer: Jonathan Rivera

JohnJankovich2nd reviewer: Ujagar BhachuTo Fees 6/13/2003.Ret'd from Fees 7/15/2003.Closed 12/4/2003. Newinactivation certificate number: NR-394-D-802-S. ADAMsPackage: ML033300172

12/08/2003 03-44 Rivera 3 United Technologies DG-1 Request to inactivate NR-655-

D-102-S.1st reviewers: J. Rivera & U.Bhachu2nd reviewer: J. JankovichTo Fees 6/26/2003.Package: ML031770158Ret'd from Fees 7/15/2003.Closed 12/8/2003.New certificates issued:NR-8139-D-801-S, NR-8139-D-802-S & NR-8139-D-803-S.ADAMs PackageML033360559

6 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

12/11/2003 03-46 Yin 1 21st Technologies, Inc. Gun Sights Resumittal of previous

amendment request.Amendment to NR-365-D-101-E to sell luminous rifle/gunsights to Insight Technology.1st reviewer: Xiaosong Yinand UjagarBhachu2nd reviewer: John JankovichTo Fees 7/7/2003ADAMs Package #: ML031880721They will also be amendingtheir E-license as well 42-238850-02E.Please reference previouscase SSD 03-03.Ret'd from Fees 7/15/2003.Case discontinued 12/11/2003by letter to Kevin Romney. ML033450416

01/09/2004 03-47 Kirkwood

4 MDS Nordion GammaMed 12it, 12i, 212, 232

Request to inactivate NR-220-D-121-S, NR-220-S-123-S, &NR-220-S-124-S.1st reviewers:Tony Kirkwood,J.Jankovich2nd reviewer: Ujagar BhachuTo Fees 7/14/2003.Returned from Fees8/21/2003.Closed out 1/9/2004 byissuance of inactivatedregistration certificates NR-220-D-832-S, NR-220-S-833-S, NR-220-S-834-S & NR-220-D-835-S to Marc-AndrTCharette of MDS Nordion. Allcertificates and letter wereplaced in the ADAMs packageaccordingly. ML031950508.

7 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

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Reviewer

CompanyModel Numbers Status

01/30/2004 03-49 Kirkwood

1 Kidde Fenwal CPD-705X Request to amend NR-668-D-101-E. There is also arequest to amend their E-license as well. (20-15285-03E). Tony Kirkwood will beassigned to both actions.1st reviewers: John Jankovich2nd reviewer: Ujagar BhachuTo Fees 8/5/2003.ADAMs Package: ML032170321Returned from Fees8/21/2003.Case completed January 30,2004 by issuance of letter toKidde-Fenwal (Terry Garland)and amended registrationcertificate NR-668-D-101-E.

02/17/2004 04-17 Ashkeboussi

1 U.S. Dept. of the Navy C2106-AB00, C2106-AC00

Request to inactivateregistration certificate NR-470-S-101-S per e-mail datedFebruary 3, 2004.1st reviewers: Nima and JohnJankovich2nd reviewer: Ujagar BhachuTo Fees 2/5/2004.ADAMS Package: ML040360236Closed out 2/17/2004 by letterto Dave Farrand enclosinginactive registration certificateNR-8143-D-801-E & NR-8143-S-802-S.Previously inactivatedcertificate NR-470-D-801-Ehad been transferred to NR-8143-D-801-E. NR-8143-S-802-S is replacing NR-470-S-101-S.

8 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

02/18/2004 04-06 Ashkeboussi

2 BSI Instruments, Inc. LB 7400 D, F, and L Series

Request to inactivateregistration certificates NR-112-D-102-B and NR-112-D-103-B per and e-mail fromEdwina Milicic to UjagarBhachu dated October 20,2003.1st reviewers: Nima A. andUjagar B.2nd reviewer: JohnJankovichTo Fees 10/20/2003.Ret'd from Fees 1/7/2004.Case completed February 18,2004, by letter to EdwinaMilicic with enclosure of NR-112-D-811-B (replaces NR-112-D-102-B) & NR-112-D-812-B (replaces NR-112-D-103-B).ADAMs Package: ML032940182

02/20/2004 04-11 Ashkeboussi

1 Research Appliance Co.

Tracerlab SP-100

Inactivation of NR-568-D-101-U. No incoming letterrequesting inactivation.1st reviewer: NimaAshkeboussi JohnJankovich2nd reviewer: Ujagar BhachuTo Fees 12/11/2003.ADAMs Package: ML033450087Ret'd from Fees 1/7/2004.Closed out 2/20/2004 byissuance of new registrationcertificate NR-8141-D-101-S.

9 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

02/25/2004 04-01 Ashkeboussi

1 MDS Nordion Gammacell 3000

Request to amend NR-220-D-102-S for the Gammacell 3000source holder packages.1st reviewers: Nima A. &John J.2nd reviewer: Ujagar BhachuRet'd from Fees 1/7/2004.Case closed 2/25/2004 byletter to MDS Nordion withamended registrationcertificate NR-220-D-102-Sdated 2/25/2004.ADAMs Package: ML040510032.

10 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

03/09/2004 04-22 Ashkeboussi

16 General Motors Gamma Ray, FSD-39381

Termination request ofregistration certificates NR-292-D-101-S & NR-315-D-101-S.1st reviewers: Nima A. &John Jankovich2nd reviewer: Ujagar BhachuTo Fees 2/18/2004.ADAMs Package: ML040490781Closed out March 2, 2004 byissuance of the followingcertificates:NR-8144-D-801-S, NR-8144-S-802-S, NR-8144-D-803-S,NR-8144-D-804-S,NR-8144-D-805-S, NR-8144-S-806-S, NR-8144-S-807-S,NR-8144-S-808-S,NR-8144-S-809-S, NR-8144-D-810-S,NR-8144-D-811-S,NR-8144-D-812-S,NR-8144-D-813-S, NR-8144-D-814-S, NR-8144-D-815-S.

New certificates are datedMarch 9, 2004, as well as theoutgoing letter to Mr. Kilgore.

Old certificates:

NR-0315-D-801-U, NR-0315-S-802-U, NR-0315-D-803-U,NR-0315-D-804-U, NR-0315-D-805-U, NR-0315-S-806-U,NR-0315-S-807-U, NR-0315-S-808-U, NR-0315-S-809-U,NR-0315-D-810-U, NR-0315-D-811-U, NR-0315-D-812-U,NR-0315-D-813-U, NR-0315-D-101-S, NR-0292-D-101-SThis case originally wasmarked as having 2 actions,however; after reviewing theapplication there were actually16 actions involved.Form ret'd from Fees10/6/2004.

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03/10/2004 04-26 Ashkeboussi

1 21st Century Tech. Bow Sights Lumitec's name changed21st Century - new address1st reviewers: Nima and JohnJ.2nd reviewer: UjagarADAMs Package: ML040560639To Fees 2/25/2004Case Void March 10, 2004due to insufficient information.Form ret'd from Fees10/6/2004.

03/12/2004 04-25 Rivera 1 Trijicon M203 Request to amend registration

certificate NR-418-D-101-E.1st reviewers: Rivera &Jankovich2nd reviewer: BhachuADAMsPackage:ML040560635To Fees 2/25/2004.Closed out March 12, 2004, byletter to Darin Schick ofTrijicon along with amendedcertificate NR-418-D-101-Eand Amendment 9 to their E-license.Form ret'd from Fees10/6/2004.

03/22/2004 04-07 Rivera 1 Mentor Pd-103 SH & Pd-103 SL

Amendment to NR-1081-S-101-S in the construction oftheir Palladium-103 seed.1st reviewers: J. Rivera/U.Bhachu2nd reviewer: J. JankovichADAMs PackageNumber:ML033010565Ret'd from Fees 1/7/2004.Case closed out March 22,2004. Letter sent to StevenJackson along withamendment NR-1081-S-101-S. Letter and certificate faxedto Mr. Jackson 3/22/04.

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Model Numbers Status

03/23/2004 04-21 Yin 1 Schlumberger H-245258 (NSR-M)

Inactivation request to cancelNR-524-S-104-S. Duplicatecertificate with the State ofTexas.1st reviewers: Xiasong Yin,J.Jankovich2nd reviewer: Ujagar BhachuTo Fees 2/18/2004.ADAMS Package: ML040490777Case closed out via letter andnew issuance of registrationcertificate NR-8134-S-804-Swhich replaced NR-524-S-104-S. Everything is now in thepackage noted above inADAMS.Form ret'd from Fees10/6/2004.

03/23/2004 04-24 Yin 1 Trilux Technologies, Inc. FB, FBW, FP, RBW, RHP, RLP,

SG Series Request to terminatedregistration NR-1028-D-101-Ein their entirety.1st reviewers: Xiasong Yin,Jankovich2nd reviewer: Ujagar BhachuTo Fees 2/20/2004.ADAMS Package: ML040510281.Xiasong assigned to E-licensetermination as well.Document closed out3/23/2004 via letter and newissuance of registrationcertificate NR-8145-D-801-Ewhich replaces NR-1028-D-101-E. Everything has beenplaced into ADAMs and is inthe Trilux folder under SSDCase 04-24.Form ret'd from Fees10/6/2004.

13 Materials Safety & Inspection Branch

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04/01/2004 04-04 Rivera 1 Agilent Technologies G1223A, G1533A, G2310A,

G2330A, G2397A Request to amend registrationcertificate NR-348-D-111-B.1st reviewers: J.Rivera/U.Bhachu2nd reviewer: J. JankovichTo Fees 10/9/2003.Ret'd from Fees 1/7/2004.Closed April 1, 2004 by letterto Keith Morgan of Agilentenclosing amended certificateNR-348-D-111-B.

04/05/2004 04-09 Yin 1 Systems & Electronics,

IncISO 9001 New SS&D application.

Check #334051 for $5,700rec'd.1st reviewers: Yin &Jankovich2nd reviewer: U. BhachuAlso, an new exemptdistribution license request. Check #334052 for $4,300.Xiaosong Yin to do e-licensepart and Tony Kirkwood will besigning the license. To Fees 11/17/2003.Ret'd from Fees 1/7/2004.TAC Number: L20897.Deficiency response sent out2/17/2004.Case discontinued by letter toAllan Kaste of Systems &Electronics, Inc. for both thess&d and the e-licenserequest due to insufficientinformation. Case will bereopened if they resubmit.

14 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

04/13/2004 04-10 Yin 1 System Sensor 1000K, 500A, 500B, 700A Series

Amendment request to addphysical distribution from aHoneywell owned, controlled,and operated maquiladorafacility in Juarez, Mexico.1st reviewer: Xiaosong Yin &J. Jankovich2nd reviewer: Ujagar BhachuTo Fees 11/24/2003.Amendment to both SSD & E-license. SS&D Package: ML033280108E-License Package: ML033280105Xiaosong is doing both SS&D& E-license.Ret'd from Fees 1/7/2004.Case discontinued April 13,2004 due to insufficientinformation.

04/14/2004 04-33 Ashkeboussi

1 Trijicon Insight-F, Insight-R, Variousothers also

Request to amendtypographical error onregistration certificate NR-418-D-101-E.Request received 4/8/2004from Darin Schick of Trijicon.1st reviewers: Nima &Xiaosong2nd reviewer: JohnJankovichTo Fees 4/8/2004.Case closed April 14, 2004;with letter to Darin Schick ofTrijicon enclosing correctedregistration certificate NR-418-D-101-E.Form ret'd from Fees10/6/2004.

15 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

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CompanyModel Numbers Status

04/29/2004 04-18 Ashkeboussi

1 U.S. Dept. of the Army M67 Request to withhold the M64carrying case from registrationcertificate NR-155-D-126-S.1st reviewers: Xiaosong Yin2nd reviewer: JohnJankovichTo Fees 2/12/2004.ADAMs Package: ML040430309.Closed out by letter to Dept. ofthe Army and amendedregistration certificateNR-155-D-126-S.

04/30/2004 04-08 Rivera 1 Radiation, Safety & RSNP-AU Gold-198 Seeds

Amendment request - NR-569-S-101-S.ML033090259.1st reviewers: Rivera &Jankovich2nd reviewer: BhachuTo Fees 11/5/2003.Ret'd from Fees 1/7/2004.Vendor #8147 assigned forinactivation.ADAMs Package: ML033090423.Closed out April 30, 2004; byletter to Edd Johnsonenclosing inactivatedregistration certificates NR-8147-S-802-S (previously NR-569-S-101-S) & NR-8147-S-801-S (previously NR-569-S-801-S).

05/03/2004 04-29 Yin 1 Sabia, Inc. S-3 Request for a new device

containing Cf-252.1st reviewers: Xiaosong &Ujagar2nd reviewer: JohnJankovichADAMS Package: ML040790429To Fees 3/19/2004.TAC #: L20902Case withdrawn per licensee -5/3/2004.

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05/06/2004 04-34 Ashkeboussi

1 IMS Systems 5301 & 5301-1

Request to amend registrationcertificate NR-1102-D-104-S.1st reviewer: NimaAshkeboussi2nd reviewer: John JankovichTo Fees 4/14/2004ADAMs Package: ML041050413.Case closed May 6, 2004; byletter to IMS Systems, Inc.(Vickie Allen) enclosingcorrected Page 6 of NR-1120-D-104-S.

05/13/2004 04-13 Herrera 5 Siemens Medical of

AmericaCaesa-Gammatron, Gammatron1, 2, & 3

Inactivation of registrationcertificates:NR-606-S-101-U, NR-606-D-102-U, NR-606-D-103-U, NR-606-D-104-U, & NR-606-D-105-U.1st reviewers: Tomas Herrera JohnJankovich2nd reviewer: Xiaosong YinTo Fees 12/11/2003.Start date subject to changeupon arrival of incoming letterfrom Siemens.ADAMs Package: ML033450141Ret'd from Fees 1/7/2004.Case closed out May 13,2004. New inactive vendornumber assigned was NR-8148-D-801-U, NR-8148-D-802-U, NR-8148-D-803-U, NR-8148-D-804-U & NR-8148-D-805-U.

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CompanyModel Numbers Status

05/19/2004 04-41 Kime 1 21st Century

Technologies Bow Sights Lumitec's name changed

21st Century - new addressAmendment to NR-365-D-101-E.Also, John Jankovich will beanswering a deficiencyquestion as well. E-licensewill also be issued (new) whichBruce Carrico is assigned.1st reviewers: Traci Kime andJohn J.2nd reviewer: Xiaosong YinPrevious case was 04-26which was void March 10,2004 due to insufficientinformation. ADAMs Package: ML041340033To Fees 5/13/2004.Closed out May 19, 2004; byletter to Dixie Wells-O'Douenclosing new NRC License27-23914-01E and amendedregistration certificate NR-365-D-101-E.Form ret'd from Fees10/6/2004.

05/20/2004 04-40 Ashkeboussi

1 betacontrol of America MK 1.0 Request to amend registrationcertificate NR-122-D-101-B. 1st reviewers: Nima A. &John J.2nd reviewer: Xiaosong YinAlready placed into ADAMs. Corrected copy is already onADAMs.To Fees 5/12/2004.ADAMs Package: ML041330332.Case discontinued May 20,2004. The company hadsignificant deficiencies in theirapplication.Form ret'd from Fees10/6/2004.

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Closed Sealed Source & Device Actions

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CompanyModel Numbers Status

05/25/2004 04-32 Ashkeboussi

1 Seaman NuclearCorporation

CDC.800, GT-GHP, HEG-137,AMN.PE5, AMN.V997

Amendment of NR-587-D-104-S to add additionalcombinations of sources forthe C-300 Series of gauges.1st reviewers: Ashkeboussi &Jankovich2nd reviewer: YinTo Fees 4/5/2004ADAMs Package: ML040960205.Case completed May 25,2004. Case was under anexpedited review.Form ret'd from Fees10/6/2004.

06/03/2004 04-12 Rivera 3 Minnesota Mining 3F1G, 4F6Y

Inactivation of NR-459-S-101-S, NR-459-S-102-S, & NR-460-S-897-S.1st reviewers: JonathanRivera JohnJankovich2nd reviewer: Xiaosong YinTo Fees: 12/11/2003.ADAMs Package: ML033450101.Ret'd from Fees 1/7/2004.Case closed out June 3, 2004by issuance of letter to RichHolland enclosing inactivatedregistration certificates NR-8008-S-801-S, NR-8008-S-802-S

19 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

06/09/2004 04-27 Ashkeboussi

1 SAIC IM239 Air Monitor, Small CAD

Amendment request to includetwo additional devices withinstalled exempt radioactivematerial sources for E-license04-23909-01E.They are also requesting anew sealed source anddevice.ADAMs Package: ML040640322.TAC #L20901 for ss&d.To Fees 3/4/2004.Check received May 17, 2004in the amount of $5,700.00from SAIC.SS&D part of review closedout June 9, 2004. Nima still hasthe case until the E-licensepart is complete so that boththe ss&d and E-license can bedistributed together.Form ret'd from Fees10/6/2004.

06/09/2004 04-14 Rivera 5 GE Ion Track Itemiser 2 & 3, Vapor Tracer 2,

Entryscan 3 New application for exemptlicensing of GE Ion Track'sproducts. 1st reviewers: JonathanRivera JohnJankovich2nd reviewer: Xiaosong YinTo Fees 12/16/2003.TAC #L20898ADAMs Package: ML033500395Licensee informed us that theycannot provide us a response. Therefore, we closed out thecase, effective June 9, 2004,when the licensee notified us. We will open a new case whenthe response comes in.

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CompanyModel Numbers Status

06/10/2004 04-15 Kirkwood

1 MTI Industries, Inc. Smoke Detectors

Response to e-mail and letterof 12/1/2003, requesting add'linfo from previous request(ssd case 03-41) applicationfor device review for MTIIndustries, Inc. to distributesmoke detectors that aremanufactured in Hong Kong.Check #23238 paid in theamount of $5700 for devicereview.They are also seeking anexempt distribution license aswell.Check #23237 paid in theamount of $2400 for licensereview.Both checks sent to lock box6/10/2003.1st reviewers: Tony Kirkwood& JohnJankovich2nd reviewer: Xiaosong YinTo Fees 12/17/2003.TAC #L20899 (previous TACL20894)Returned from Fees8/21/2003.RAI sent out 11/14/2003 to Mr.Widomski.Case voided 12/1/2003. ML033350415.Ret'd from Fees 1/7/2004.Deficiency Letter sent tolicensee March 9, 2004.Case closed out June 10,2004; by issuance ofregistration NR-1203-D-101-Eand E-license 12-23905-01E.

21 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

06/10/2004 04-35 Yin 1 System Sensor 1000K, 500A & B & 700A Series

Amendment request for devicesheet NR-547-D-101-E to addthe following sources for use: SM-1x series for registry IL-547-S-102-S, & AMM.1001,AMM.1001H & AMM.1001Dfor registry MA-1059-S-174-S.1st reviewer: Xiaosong Yin2nd reviewer: John JankovichTo Fees 4/14/2004.ADAMs Package: ML041050416.Closed out June 10, 2004. Sources were added tocertificate NR-547-D-101-E.Basically, 04-35 & 04-45 wereclosed the same day with oneissuance of the registrationcertificate NR-547-D-101-E. 04-10 was also a SystemSensor file, however; that onewas discontinued; to to lack ofinformation previously.Form ret'd from Fees10/6/2004.

22 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

06/10/2004 04-45 Yin 1 System Sensor 1000K, 500A, 500B, 700A Series

Amendment request to addphysical distribution from aHoneywell owned, controlled,and operated maquiladorafacility in Juarez, Mexico. Previous ss&d case was 04-10.Amendment to both SSD (NR-547-D-101-E) & E-license.1st reviewer: Xiaosong Yin2nd reviewer: John JankovichTo Fees 6/2/2004.ADAMs Package: ML041540511.Closed out June 10, 2004. Distribution was added to NR-547-D-101-E.Basically, 04-45 & 04-35 wereclosed the same day with oneissuance of the registrationcertificate NR-547-D-101-E. 04-10 was also a SystemSensor file, however; that onewas discontinued; to to lack ofinformation previously.Form ret'd from Fees10/6/2004.

06/18/2004 04-46 Herrera 2 Universal Security SS-750 Series, SS-770 Series

Amendment to certificate NR-657-D-101-E to correctdistributor/manufactureraddress & to certificate NR-657-D-102-E for UniversalModels SS-200 & SS-300.1st reviewer: Traci Kime2nd reviewer: John JankovichTo Fees June 8, 2004.ADAMs PackageNumber:ML041600219Case completed June 18,2004; by letter to StevenBabinec of USI, Inc. andamended certificate NR-657-D-101-E.Form ret'd from Fees10/6/2004.

23 Materials Safety & Inspection Branch

Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

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CompanyModel Numbers Status

06/28/2004 04-16 Ashkeboussi

1 Ingersoll-Rand Smoke Detector

Request to incorporate anionization-type smoke detectorinto LCN's product line tocreate a product that wouldhold a door open until thedetector senses smoke thencloses the door. LCN is thedoor closer manufacturer.1st reviewers: Nima A. &John Jankovich2nd reviewer: Xiaosong YinTo Fees January 20, 2004.ADAMs Package: ML040200687.Case completed June 28,2004. E-license part of this case wasfinally closed out on January6, 2005, by issuance oflicense 12-19544-03E.NR-1214-D-101-E was alsoissued but was completed on6/28/2004. Both the ss&d andthe e-license were distributedtogether on January 10, 2005.

07/07/2004 04-36 Yin 1 DraxImage LS-1 Amendment request to

registration NR-1121-S-101-Sfor brachytherapy LS-1.1st reviewer: Xiaosong Yin2nd reviewer: John JankovichTo Fees 4/26/2004.ADAMs Package: ML041170103Closed out July 7, 2004 byletter to Ed Bump enclosingamended registrationcertificate NR-1121-S-101-S.Form ret'd from Fees10/6/2004.

24 Materials Safety & Inspection Branch

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Reviewer

CompanyModel Numbers Status

07/09/2004 04-31 Yin 1 Advanced Measurement

Solid Sealed Source

Application for a newdistribution license. XiaosongYin is the first reviewer alongwith Tony Kirkwood. JohnJankovich will be the secondreviewer. Xiaosong isassigned both the ss&d andthe e-license review for thiscase. ADAMs PackageNumber is: ML040910466.

Check sent in the amount of$4,300.00 (Check #025362.To Fees 4/1/2004.Closed out July 9, 2004. Itwas determined that an ss&dreview was not necessary forthis case.

07/12/2004 04-50 Ashkeboussi

1 Tyco Safety Products Lo-Pro Series 612I & 912I

Name & Address ChangeOnly!!!ADAMsPackage:ML041880317.To Fees July 6, 2004.Also has an E-licenseamendment as well. (20-23881-01E).Case closed out with issuanceof letter to Larry Starnesenclosing amendment ss&dregistration certificate NR-1156-D-101-E dated July 9,2004 & exempt distributionlicense 20-23881-01E datedJuly 12, 2004.Form ret'd from Fees10/6/2004.

25 Materials Safety & Inspection Branch

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CompanyModel Numbers Status

07/19/2004 04-38 Rivera 1 GE Ion Track 97, 97A/VIXEN

Request to inactivateregistration certificate NR-399-D-102-E per GE Ion Track'sletter dated May 19, 2003; andNRC's fee letter dated July 23,2003.1st: Jonathan Rivera andJohn Jankovich2nd: Xiaosong YinTo Fees May 4, 2004.ADAMs Package: ML041250240.The SSD reviewers finishedthe registration sheet, butthere is more work with the e-license, Xiaosong is stillworking on the license. Sincethere is no definite date forfinishing the e-license, I askyou to close out the SSD casein the case work trackingsystem, on the basis of this e-mail, effective July 19, 2004. We will mail out theregistration sheet together withthe e-license when it getsdone.Form ret'd from Fees10/6/2004.

07/20/2004 04-20 Chang 1 Harrel, Incorporated AMC.D3 Request to amend IL-136-S-

145-S to list AEA Technology,QSA, Inc. Model AMC.D3.1st reviewers: R. Chang &J.Jankovich2nd reviewer:Xiaosong YinADAMSPackage:ML040490773To Fees 2/18/2004.Case closed out with issuanceof amended registrationcertificate NR-342-D-101-G.Form ret'd from Fees10/6/2004.

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Reviewer

CompanyModel Numbers Status

07/21/2004 04-42 Herrera 2 Marathon Watch Co.,

Ltd. 211, 348A, 350A, 359

Application for amendment toNR-505-D-101-E to add twonew models.1st reviewers: Herrera &Jankovich2nd reviewer: Xiaosong Yin.ADAMsPackage:ML041460093To Fees 6/1/2004.This case also involves an E-license amendment as well.Closed out July 21, 2004 byletter to Marathon Watchenclosing amendment 1 totheir E-license 54-28526-01E& their amended registrationcertificate NR-505-D-101-E.

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

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CompanyModel Numbers Status

07/26/2004 04-19 Herrera 1 Environics M-90 Chemical Warfare Agent

Detector Amendment request topossess, manufacture, anddistribute the Environics M-90Chemical Warfare AgentDetector and Environics ModelMGD-1 Multiple Gas Detectoron registration certificate NR-174-D-101-E.1st reviewers: T. Herrera & J.Jankovich 2nd reviewer: Xiaosong YinThis case also involves anamendment to E-license. Tomas will do the E-licensetoo.To Fees 2/17/2004.Deficiency Letter sent tolicensee March 10, 2004.RAI sent to Environics,7/12/2004This morning I spoke with RolfMeinholtz, telephone number 386-304-5252, of Environics,USA. In our conversation Mr. Meinholtz explained thatbecause of the NationalFinnish Holiday, lasting for amonth, he was not sure thathe could get the informationwe requested from the vendorin Finland within the 30 daysstated in our request foradditional information. Pleaseclose out this case, and wewill re-open it when we receivethe information, which shouldonly be a matter of days.Form ret'd from Fees10/6/2004.

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CompanyModel Numbers Status

07/27/2004 04-23 Kirkwood

2 Department of the Army

GID-3, CAM, ICAM

Request to amend registrationcertificates NR-1129-D-101-S& NR-1129-D-103-S to havethe leak test changed fromannually to prior tomaintenance or repairoperations.1st reviewers: Tony Kirkwood,Jankovich2nd reviewer: Xiaosong YinTo Fees 2/19/2004.ADAMS Package: ML040490786.Defciency letter sent out May19, 2004.Deficiency response rec'd6/24/04.Closed out July 27, 2004; byissuance of letter to GeorgeJarvis and amendedregistration sheet NR-1129-D-103-S.Form ret'd from Fees10/6/2004.

07/28/2004 04-48 Kime 3 IMS Systems, Inc. 5245-xx series, 5321, 5301 &

5301-1 Address Change Only!!!Certificates: NR-1120-D-101-S, NR-1120-D-103-S, & NR-1120-D-104-S.1st: Traci Kime, JohnJankovich2nd: Xiaosong YinTo Fees June 10, 2004.ADAMs Package: ML041620548Gave to John Jankovich forreview on June 29, 2004.Closed out July 28, 2004 byletter to Vickie Allen enclosingupdated registration sheets,NR-1120-D-101-S, NR-1120-D-103-S, & NR-1120-D-104-S.Form ret'd from Fees10/6/2004.

29 Materials Safety & Inspection Branch

Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

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For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

08/10/2004 04-30 Kime 20 Department of the Army

Various Request for change to

distributor address for thefollowing registrationcertificates:

NR-155-S-101-S, NR-155-S-102-S, NR-155-S-103-S, NR-155-S-104-S, NR-155-S-105-S, NR-155-S-106-S, NR-155-S-107-S, NR-155-S-108-S,NR-155-S-109-S, NR-155-S-110-S,NR-155-S-111-S, NR-155-S-112-S, NR-155-S-113-S, NR-155-S-114-S, NR-155-S-115-S, NR-155-S-116-S, NR-155-S-117-S, NR-155-D-120-S,NR-155-D-124-S, NR-155-D-126-S.ADAMs Package: ML0409103571st reviewers: Traci Kime & T.Kirkwood2nd reviewer: JohnJankovichTo Fees 3/31/2004.Gave to John Jankovich forreview on June 1, 2004.Closed out by issuance ofabove-noted registrationsheets to show new addresson August 10, 2004.Form ret'd from Fees10/6/2004.

30 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

08/16/2004 04-37 Herrera 1 U.S. Dept. of Energy SR-CF-100, SR-CF-3000, & SR-

CF-2000 Series Inactivation request via letterfrom Bob Carlson dated April14, 2004. Certificate numberNR-277-S-107-S.1st reviewer: John Jankovich2nd reviewer: Xiaosong YinTo Fees 4/28/2004.ADAMs Package: ML041210868Letter sent 6/17/04 to the Deptof Energy for a request toinactivate (RAI).Case closed out by letter toLarry Boyd and issuance ofinactivated registrationcertificate NR-277-S-803-Sdated August 16, 2004.Form ret'd from Fees10/6/2004.

08/19/2004 04-51 Herrera 1 Meprolight, Inc. ML-100, 1150, 115P, 200A, 260,

300A, 300N etcAmendment to registrationcertificate NR-1119-D-101-Eto include an additionallocation in Islip, New York.To Fees 7/7/2004.ADAMs Package: ML041890352.1st rev's: T. Herrera & X. Yin2nd rev: J. JankovichClosed August 19, 2004 byissuance of amendedcertificate NR-1119-D-101-E.Form ret'd from Fees10/6/2004.

31 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2003 to 09/30/2004

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

08/23/2004 04-28 Rivera 1 Meprolight, Inc. ML-442xx Series Watches, 443,

444, 447, 448 Request to inactivate devicesheet NR-1119-D-102-E forMeprolight Tritium IlluminatedWatches and Gauges.ADAMs Package: ML0406403251st reviewers: Jonathan &Xiaosong Yin2nd reviewer: John JankovichTo Fees 3/4/2004.Case closed 8/23/2004 byissuance of inactive certificateNR-1119-D-801-E whichterminated NR-1119-D-102-E.Form ret'd from Fees10/6/2004.

09/13/2004 04-43 Yin 1 Cammenga &

Associates 13208E4680

Request to amend NR-210-D-101-E to add a new model.1st reviewer: Xiaosong Yin2nd reviewer: John JankovichADAMsPackage:ML041460096Deficiency Letter mailed out7/29/2004.Cammenga officiallyrequested to abandon theirMay 18, 2004 amendmentrequest in a letter to NRCdated August 31, 2004.

Form ret'd from Fees10/6/2004.

Total Completed Case(s) is 59 Totaling 120 Action(s)

32 Materials Safety & Inspection Branch

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Attachment DSection 4 of 4

List of SS&D Cases

Completed between 10/1/2004 - 7/15/2005

(listed in order of completion date)

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Sealed Source & Device ActionsFor Fiscal Year 2005

MSIB-A StatisticsMonth Received Completed Pending

October 8 4 16November 4 3 17December 3 4 16January 5 4 17February 3 3 17

March 4 12 9April 3 5 7May 7 9 5June 6 2 9July 2 0 11

August 0 0 11September 0 0 11

TOTALS 45 46 11

Fee Statistics FeeCategory

Total Actions Requiring Fees Not Requiring Fees

Pending*

Completed Pending* Completed Pending* Completed

9AA 28 28 3 2 25 26

9AN 4 7 4 7 0 0

9BA 0 0 0 0 0 0

9BN 2 2 2 2 0 0

9CA 6 3 1 0 5 3

9CN 5 5 5 5 0 0

9DA 0 0 0 0 0 0

9DN 0 1 0 1 0 0

Totals 45 46 15 17 30 29* Pending Actions under Fee Statistics only includes Fiscal Year data. Materials Safety and InspectionBranch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

10/06/2004 04-47 Herrera 1 betacontrol of America MK 1.0 Amendment request to

certificate NR-122-D-101-B. Previous ss&d case 04-40which was discontinued May20, 2004; due to lack ofinformation.1st: T. Herrera & J. Jankovich2nd: J. JankovichTo Fees 6/8/2004.ADAMs Package: ML041600329RAI sent out August 2, 2004 toMr. Hannig.Def. response rec'd August27, 2004.Form ret'd from Fees10/6/2004.Closed out 10/8/2004 by letterto Markus Hannig ofBetacontrol enclosingamendment registrationcertificate NR-122-D-101-B.

10/08/2004 04-44 Yin 1 Smith's Detection IonScan 100, 200, 250, 300, etc.

Request to amend NR-163-D-103-G to add another model tothe sheet.1st reviewers: Herrera &Xiaosong Yin2nd reviewer: JankovichADAMs Package: ML041460102To Fees 6/1/2004.RAI sent out July 27, 2004.Closed out 10/8/2004 by letterto Dr. Georgia Ranger of Smith'sDetection enclosingamendment registrationcertificate NR-163-D-101-G.

1 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

10/25/2004 04-54 Herrera 2 Environics M-90 Chemical Detector

Amendment request topossess, manufacture, anddistribute the Environics M-90Chemical Warfare AgentDetector and Environics ModelMGD-1 Multiple Gas Detectoron registration certificate NR-174-D-101-E.1st reviewers: T. Herrera & U.Bhachu 2nd reviewer: Xiaosong YinThis case also involves anamendment to E-license. Tomas will do the E-licensetoo.To Fees 8/18/2004.previous ss&d case 04-19.Form ret'd from Fees10/6/2004.Case closed out October 25,2004; by letter to RolfMeinholtz enclosing E-License09-23918-01E & ss&d sheetNR-1160-D-102-E &terminated license numbers45-23885-02E, 45-25316-03E& inactivated registrationsheet NR-8153-D-801-E.

2 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

11/01/2004 04-52 Yin 1 Systems & Electronics,

IncISO 9001 New SS&D application.

Check #334051 for $5,700rec'd.(previous case 04-09)1st reviewers: Xiaosong Yin 2nd reviewer: JohnJankovichAlso, an new exemptdistribution license request. Check #334052 for $4,300.Xiaosong Yin to do e-licensepart also To Fees 7/26/2004.

TAC Number: L20897.Deficiency response sent out2/17/2004. Case discontinuedby letter to Allan Kaste ofSystems & Electronics, Inc. forboth the ss&d and the e-license request due toinsufficient information. Casewill be reopened if theyresubmit. Form ret'd fromFees 10/6/2004. Case closedout November 1, 2004; byletter to Allan K. Kasteenclosing new e-license 24-23912-02E and new ss&dsheet NR-1224-D-101-E.

11/02/2004 04-39 Yin 1 Sabia, Inc. Model S-3 source housing

Request for a new devicecontaining Cf-252 by letterdated May 3, 2004.1st reviewers: Xiaosong Yin 2nd reviewer: JohnJankovich ADAMS Package: ML041270278 To Fees5/6/2004. TAC #: L20903Previous ssd case number 04-29 which was withdrawn perlicensee on 5/3/2004.deficiency letter sent out July1, 2004; ML041880059.Deficiency letter sent out9/13/2004.Deficiency response rec'd10/4/2004.

3 Materials Safety & Inspection Branch

Closed Sealed Source & Device Actions

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By Date Completed for the period 10/01/2004 to 07/15/2005For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

11/04/2004 05-05 Rivera 1 GE Ion Track 97, 97A/Vixen Request to inactivate

certificate NR-399-D-102-E.1st: J. Rivera2nd: J. JankovichADAMs Package: ML042940485To Fees: October 20, 2004.Case closed November 4,2004; by issuance of letter toTim Brandon enclosinginactivated registration sheetNR-399-D-802-E whichreplaces NR-399-D-102-E.Returned from Ros Jones(Fees) July 19, 2005.

12/08/2004 04-49 Herrera 1 Met One Instruments E-Bam Device

Request to amend E-BamDevice Registration CertificateNR-1124-D-101-E and ExemptDistribution License 36-23875-01E to include the BAM-1030.1st reviewer: Herrera &Jankovich2nd reviewer: Xiaosong YinADAMsPackage:ML041740418(SS&D) ADAMs Package:ML041740417 (E-license) ToFees 6/22/2004.RAI sent 8/16/2004 to RonSiebert: ML042290468.Form ret'd from Fees10/6/2004. Met Oneresponded to our RAI. Wereceived the package10/12/04. SSD portion of casecompleted 12/8/2004. E-license portion to followshortly. E-license signed anddistributed January 25, 2005. License Number 36-23875-01E.

4 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

12/08/2004 05-07 Herrera 1 betacontrol of America, MK 1.0, BC MK 1.0

Amendment request ofregistration sheet NR-122-D-101-B.1st: Tomas Herrera/JohnJankovich2nd: Nima AshkeboussiPackage: ML043130179To Fees: 11/8/2004.Closed out 12/8/2004 by letterto Markus Hannig enclosingcorrected registrationcertificate NR-122-D-101-B.Returned from Ros Jones(Fees) July 19, 2005.

12/21/2004 04-53 Herrera 1 NASA-Goddard Space

Flight 672 Custom Irradiator

Application for a model 672custom irradiator.1st: Herrera/Jankovich2nd: YinTo Fees 8/3/2004Package: ML042160084Deficiency letter sent to TedSimmons on November 22,2004. ML043270514.Case closed out 12/21/2004. NASA-Goddard Space FlightCenter. stated that they arestill in the process of gatheringthe information we requestedin our RAI dated 11/22/2004. They were not sure when theywould have it by. When theysubmit their response, we willopen a new case and assign anew case number.

5 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

12/22/2004 05-03 Ashkeboussi

1 GE Ion Track Entryscan 3e Amendment to license numberNR-399-D-101-E & 20-23904-01E.GE Ion Track is introducing anew model based on itsEntryscan 3 device. TheEntryscan 3 will still beproduced, but a modifiedversion known as theEntryscan3E will be introducedas a new model in the nearfuture.ADAMs package: ML0429201241st reviewers: NimaAshkeboussi 2nd reviewer: John JankovichTo Fees 10/18/2004.Closed out December 22,2004.Returned from Ros Jones(Fees) July 19, 2005.

6 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

01/03/2005 05-11 Herrera 1 Luminox gaseous tritium light sources

Request to obtain aradioactive materialspossession license and anexempt distribution license toreceive, store, and distributepackaged Luminox timepiecescontaining less thatn 25 mCiof Hydrogen-3.1st: Tomas Herrera2nd: John JankovichPackage: ML043440459Check #11061 send in forRML in the amount of$2800.00 and Check #11060sent in for EDL in the amountof $4300.00.To Fees December 9, 2004.This case involves a new TACnumber as well, however; TACnumber can't be assigned untilMarilyn Moore's return to theoffice on 12/10/2004.TAC Number: LM0001.Case cancelled. Afterspeaking with them on thetelephone, they stated thatthey only wanted the ExemptDist. Lic.Returned from Ros Jones(Fees) July 19, 2005.

01/10/2005 05-13 Herrera 1 Agilent Technologies 19233 (general lic.), 19235

(specific lic.)) Request for correction ondevice sheet NR-348-D-109-B.

1st: Tomas Herrera2nd: John JankovichADAMs Package: ML050030267Correction made to devicesheet NR-348-D-109-B onpage 3 in the "Labeling"section of.Case closed out Jan. 10, 05.Returned from Ros Jones(Fees) July 19, 2005.

7 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

01/12/2005 05-06 Herrera 1 General Dynamics Dual Drift Tube Termination request of device

sheet NR-1167-D-101-E.1st: Tomas Herrera/JohnJankovich2nd: Nima AshkeboussiPackage: ML043130178To Fees: 11/8/2004.Closed out January 12, 2005,by letter to David Vazquezenclosing terminated license09-23887-01E Amendment 3and inactive registrationcertificate NR-8156-D-801-Ewhich supercedes previouscertificate NR-1167-D-101-E.Returned from Ros Jones(Fees) July 19, 2005.

01/24/2005 04-56 Herrera 1 MDS Nordion Therasphere Amendment request to device

sheet NR-220-D-113-S toreplace the reference to theMonarch 25.1st reviewers: TomasHerrera, U. Bhachu2nd reviewer: JohnJankovichTo Fees: 9/21/2004ADAMS Package: ML042650259Form ret'd from Fees10/6/2004.RAI sent 12/1/2004. ML043360069.Closed January 24, 2005, byletter to Marc Andre Charetteenclosing amended sheet NR-220-D-113-S.

8 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

02/08/2005 05-01 Ashkeboussi

1 Best Medical Int'l, Inc. 81-01 Series Ir-192 sources forrad therapy

Amendment request tochange model on registrationcertificate NR-187-S-101-Sfrom 81-01 to 81-01 series Ir-192 sources for radiationtherapy and cardiology.1st reviewers: Nima A. 2nd reviewer: Ujagar BhachuTo Fees 10/6/2004.ADAMs Package: ML042870574.Deficiency letter sent out12/9/2004.Cased closed 2/8/2005 byletter to Joe Wang enclosingamended certificate NR-187-S-101-S.Returned from Ros Jones(Fees) July 19, 2005.

02/11/2005 04-55 Ashkeboussi

1 SABIA, Inc. K-1000 Series

Application for a new devicedesigned for on-line analysisof bulk material flowingvertically through a 6-inchpipe.TAC Number: LM0004opened 1/5/05.Check rec'd from Fees for$5600.00 dated 11/19/2004.Case discontinued 2/11/2005due to lack of informationrec'd.

9 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

02/15/2005 05-09 Rivera 1 Brandywood

Corporation Smoke Detector

Application for an exemptdistribution license under 10CFR 170.31, Category 3.I toincorporate an Americium-241foil source into a smokedetection device fordistribution to persons exemptfrom licensing.Package: ML0432701391st: Jonathan Rivera & NimaA.2nd: John JankovichCheck received in the amountof $4,300.00 dated11/15/2004. Check #1001.To Fees: 11/22/2004.Case discontinued February15, 2005.Returned from Ros Jones(Fees) July 19, 2005.

03/03/2005 05-16 Rivera 1 Truglo TG-20, TG-231 & TG-131 Series

Amendment request to showrelocation for device sheetNR-1180-D-101-E & E-License 42-23889-01E.The move is effective2/28/2005.To Fees 1/31/2005.Package: ML050310332.2nd reviewer: Tomas HerreraClosed out March 3, 2005, byletter to TruGlo, Inc. enclosingamendment 2 to e-license 42-23889-01E & NR-1180-D-101-E.Returned from Ros Jones(Fees) July 19, 2005.

10 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

03/10/2005 05-12 Herrera 1 Competition Wireline tube block ING-101 TBT/neutron

tube WNTI-26 Request to obtain a modelING-101 TBT neutrongenerator tube device forpulsed neutron testing indrilling holes.1st reviewer: Tomas Herreraand John Jankovich2nd reviewer: NimaAshkeboussiCheck received in the amountof $5,700.00 (ck #2935).ADAMs Package: ML043630394TAC Number: LM0003.RAI sent out 2/7/2005 toMartin O'Neil (ML050380031).Vendor Code 1232 assigned2/22/2005.RAI response rec'd 2/18/05.Case closed out March 10,2005. Notification ofdiscontinuation of ss&dregistration review. Competition Wireline's requestfor a device did not need to beregistered based on theprovisions of 10 CFR 39.55(a).Returned from Ros Jones(Fees) July 19, 2005.

03/11/2005 05-17 Herrera 1 Smith's Detection IonScan 500DT

Amendment request - NR-163-D-101-G for their IonScan500DT. 1st: T. Herrera2nd: J. Jankovich. ADAMsPackage: ML050450161.To Fees February 14, 2005.Closed out March 11, 2005. Letter to Georgia Rangerenclosing amendedregistration certificate NR-163-D-101-G & a letter regardingwithholding proprietaryinformation all dated March 11, 2005. Returnedfrom Ros Jones (Fees) July 19, 2005.

11 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

03/17/2005 05-04 Herrera 4 Int'l Isotopes, Inc. INIS-SF-X.X-YY-AD, J, K, & L

Application for SS&DEvaluation & Registration I3-101504.Check 003568 sent in for$1800.00. Check sent to thelockbox 10/18/2004.1st: Tomas Herrera, NimaAshkeboussi2nd: John JankovichTo Fees October 18, 2004.ADAMs Package: ML042920400.RAI sent out 1/25/2005.We received a response to ourRAI from InternationalIsotopes Inc. on March 3, 2005.Closed March 17, 2005, byletter to John Miller issuingnew registration certificate NR-1235-S-101-S.Returned from Ros Jones(Fees) July 19, 2005.

12 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

03/17/2005 05-22 Herrera 1 Competition Wireline Tube Blocking-101 TBT/neutron

Case reopened March 15,2005.______________________________Request to obtain a modelING-101 TBT neutrongenerator tube device forpulsed neutron testing indrilling holes.1st reviewer: Tomas Herreraand John Jankovich2nd reviewer: NimaAshkeboussiCheck received in the amountof $5,700.00 (ck #2935).Previous ADAMs Package: ML043630394New ADAMs Package: ML050740073 Previous TAC Number: LM0003.New TAC Number: LM0006RAI sent out 2/7/2005 toMartin O'Neil (ML050380031).Vendor Code 1232 assigned2/22/2005.RAI response rec'd 2/18/05.Case closed out March 10,2005. Notification ofdiscontinuation of ss&dregistration review. Competition Wireline's requestfor a device did not need to beregistered based on theprovisions of 10 CFR 39.55(a).Resubmitted to Fees March15, 2005.Case completed and closedout March 17, 2005 by letter toM. O'Neil enclosing newdevice sheet NR-1232-D-101-S. Letter:ML050800334,Certificate:ML050800356,ConversationRecord:ML050800374.Returned from Ros Jones(Fees) July 19, 2005.

13 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

03/28/2005 05-15 Bhachu

2 Hauni Richmond, Inc. 2314-0-0 DS Request to inactivateregistration sheets NR-345-D-103-S & NR-345-D-104-S.1st reviewer: Ujagar Bhachu2nd reviewer: NimaAshkeboussiPackage: ML050250014To Fees 1/25/2005.Vendor Code 8155 has beenassigned.Case closed out March 28,2005, by issuance of letter toDarrell Bassinger enclosinginactivated registrationcertificates NR-8155-803-S &NR-8155-D-804-S whichreplaces certificates NR-345-D-103-S & NR-345-D-104-S. Also sent were certificatesNR-8155-D-801-S & NR-8155-D-802-S and these twocertificates replaced NR-345-D-801-S & NR-345-D-802-S alldated March 28, 05.Returned from Ros Jones(Fees) July 19, 2005.

14 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

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Reviewer

CompanyModel Numbers Status

03/28/2005 05-14 Herrera 1 Thermo Electron Corp.

Thermo Electron FH 62 C14Series Monitors

New license applications forsealed source deviceregistration and exemptdistribution license for theThermo Electron FH 62 C14Series Monitors.1st: Tomas Herrera2nd: John JankovichCk 7852 rec'd for e-license($4200.00)Ck 7853 rec'd for ssd($5600.00)To Fees January 10, 2005.ADAMs Package: ML050100089.RAI sent to Dr. Mouradian2/15/2005. (ML050460304).Case closed March 28, 2005,per e-mail from TomasHerrera as stated below:

Traci,

Please close SSD Case #05-14: Thermo Electron Corp asof today 3/28/05. I ampassing Jonathan the file sothat he may finish the ELicportion of their application, theoriginal signed SSD sheet willbe in that file. You can findthe appropriate documents inmy G: drive under ThermoElectron Corp folder.Returned from Ros Jones(Fees) July 19, 2005.

15 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

03/28/2005 05-02 Rivera 1 Hauni Richmond, Inc. Model E449260

Inactivation request forcertificate NR-345-D-105-S.1st reviewers: Jonathan &John J.2nd reviewer: Ujagar BhachuTo Fees October 14, 2004.ADAMs Package: ML042880189Inactive Vendor Code 8155has been assigned.Closed out March 28, 2005, byissuance of letter to DarrellBassinger enclosing inactiveregistration certificate NR-8155-D-805-S which isreplacing NR-345-D-105-S.Returned from Ros Jones(Fees) July 19, 2005.

04/01/2005 05-23 Ashkeboussi

1 GE Security - Pittsfield 235 Series, 305 Series, & 311Series

Letter dated March 2, 2005, toTim Harris requesting transferof control for license 18-19750-02E. IMNS noticedlater on that this also involvedan ssd amendment as well forNR-271-D-101-E.Amended NR-271-D-101-Eissued 4/1/05 and thereforeclosed accordingly the sameday. Package: ML050910316.To Fees: April 1, 2005.Returned from Ros Jones(Fees) July 19, 2005.

16 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

04/06/2005 05-24 Ashkeboussi

1 Savage Systems, Inc. Night Hawk One, Night HawkTwo

Request to terminateregistration certificate NR-1183-D-101-E dated March,22, 2005. To Fees 4/4/2005. ML Package:ML050940341. 1st: Nima Ashkeboussi2nd: Ujagar BhachuCase closed out April 6, 2005,by letter to Savage Systems,Inc. issuing inactive certificateNR-8159-D-801-E whichterminated previous certificateNR-1183-D-101-E.Returned from Ros Jones(Fees) July 19, 2005.

04/06/2005 05-21 Kime 1 Draeger Safety, Inc. 5000, 5100, 5600, 5700

Draeger Safety, Inc. inSugarland, TX is making acosmetic change to the frontpanel layout of the device forNR-1199-D-101-E to bring theunit more into line with otherequipment produced byDraeger.Package: ML050680511.1st: Traci Kime/JohnJankovich2nd: Ujagar BhachuCase closed April 6, 2005, byletter to Chris Hickling afterdetermining no amendmentwas needed to Draeger'sdevice design on registrationNR-1199-D-101-E.Returned from Ros Jones(Fees) July 19, 2005.

17 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

04/21/2005 05-10 Herrera 1 mb microtec 400/1, 400/2, 400/3, 400/4,

400/5, & 400/6 Amendment request toregistration sheet NR-446-S-102-S to correct Page 4 toreference tritium purity withORNL being the supplier.1st: Tomas & Nima2nd: John JankovichTo Fees: December 2, 2004.ADAMS Package: ML043370390.Closed out 4/21/2005, by letterto Jakob Baenziger requestingadditional information in orderto resolve their issue.Returned from Ros Jones(Fees) July 19, 2005.

04/27/2005 04-58 Rivera 1 Kidde Fenwal CPD-7054 Request to add a new model

to registration certificate NR-668-D-101-E.1st: Jonathan Rivera & UjagarBhachu2nd: John JankovichADAMs Package: ML04To Fees 9/27/2004.Form ret'd from Fees10/6/2004.E-mail sent to Kidde 3/1/2005,from JRivera to let them knowtheir request was on target.E-mail from Kidde datedMarch 2, 2005, regardingstatus check on registryamendment to Kidde-FenwalNRC Reg. Cert.Closed out 4/27/2005 by letterto Terry Garland regarding"Completion of ExemptDistribution License &Registration Certificate forSmoke Detectors.

18 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

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Reviewer

CompanyModel Numbers Status

05/10/2005 05-08 Ashkeboussi

1 Sabia, Inc. XL-Series Materials Analyzer

Application for a new devicewhich is designed for on-lineanalysis of non-hydrogenousbulk material flowing along ona conveyor belt through theModel XL-Series materialsanalyzer.1st: N. Ashkeboussi2nd: John JankovichTo Fees November 16, 2004.ADAMS: ML043210398(Package).TAC Number: L20906 opened11/16/04.RAI sent March 4, 2005; to J.Miller referencing Model XLSeries - ML050680333.RAI sent out April 13, 2005.Closed out May 10, 2005, byletter to James Millerenclosing new device sheetNR-1195-D-104-S.Returned from Ros Jones(Fees) July 19, 2005.

05/17/2005 05-30 Ashkeboussi

2 MDS Nordion Gammabeam 150A, 150B, 150C& Theratron 780-19

Inactivation of Gammabeam150A, 150B, 150C &Theratron 780-19 forregistration certificates NR-220-D-105-S & NR-220-S-118-S.1st: Nima Ashkeboussi2nd: John JankovichADAMS Package: ML051370060To Fees May 17, 2005.Closed out May 17, 2005 byletter to Marc Charetteenclosing inactivatedregistration certificates NR-220-D-836-S and NR-220-D-837-S.

19 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

05/18/2005 05-26 Ashkeboussi

1 Sentrol, Inc. 600 series, 700 series, 900series

Amendment to NR-272-D-101-E to show address change. License No. 36-23802-01Eamended April 25, 2005.1st: Nima A.2nd. John J.To Fees May 9, 2005Package: ML051290330Case closed out May 18,2005, better letter to DonnaTebbets enclosing amendedcertificate NR-272-D-101-E.ML051380527 (letter), ML051380533 (certificate).Returned from Ros Jones(Fees) July 19, 2005.

05/18/2005 05-19 Ashkeboussi

1 Cammenga &Associates

13208E4680

Amendment request forregistration certificate NR-210-D-101-E to install tritium filledvials into Wrist Compasses for"night viewing".1st reviewer: NimaAshkeboussi2nd reviewer: John JankovichTo Fees February 18, 2005.ADAMS Package: ML050490368.RAI sent 4/19/05 to M.Pastoor (ML051090049)ssd portion closed on May 18,2005, and given on to BruceCarrico for the e-license partof the case. All will be sentout at one time once Bruce isfinished the E-license portion.Returned from Ros Jones(Fees) July 19, 2005.

20 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

05/19/2005 05-20 Bhachu

2 Isolite 880-12-6-XX, L3, LTE, AC/7,A/12

Reference to January 5, 2005,letter from NRC requestingtransfer of sealed source anddevice registrations NR-579-D-101-G & NR-579-D-112-G.1st: Ujagar Bhachu2nd: John JankovichTo Fees March 1, 2005.ADAMS Package: ML050600361.Case discontinued May 19,2005. Determination madethat no such transfer can takeplace.Returned from Ros Jones(Fees) July 19, 2005.

05/25/2005 05-29 Ashkeboussi

1 International Isotopes BM06 Series (BM06-33, BM06-37, BM06-57

Transfer request of TX-1153-S-102-S to NRC.1st: Nima A.2nd: John J.Package: ML051330305To Fees 5/13/2005.Closed May 25, 2005; by letterto John Miller regarding"request to transfer TX-1153-S-102-S to the NRC.Returned from Ros Jones(Fees) July 19, 2005.

21 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

05/31/2005 05-31 Ashkeboussi

1 Smiths Detection IonScan 100, 200, 250, 350, 400,Sabre 4000

Smiths Detection request toamend registration certificateNR-163-D-101-G to reflectchange in corporation name ofSmiths Detection, Warren,Pasedena and Edgewood toSmiths Detection, Inc.1st: Nima A./ 2nd: John J.Package: ML051440258To Fees: May 24, 2005.Closed out May 31, 2005, byletter to Richard Keosian ofSmiths Detection, Inc.enclosing amended devicecertificate NR-163-D-101-G toreflect the Inc. in companyname and address change.Returned from Ros Jones(Fees) July 19, 2005.

06/08/2005 05-28 Ashkeboussi

1 DuPont Safety &Protection

PS-131, EZ-202, SC101, SC101-S, & SC202

Replace NR-1059-D-101-E tobe marketed in North Americaby E.I. duPont and it'sConsumer Safety Business.Application for a exemptlicense under 10 CFR 32.26authorizing distribution ofsmoke detectors containingAm-241to persons exemptfrom licensing. 1st: Nima A.2nd: Bhachu UPackage: ML051320227 TAC #:LM0008 Check sent in theamount of $4,200.00.Case completed June 8, 2005. Letter Requesting Withholdingfrom Public Discloure wassent out June 9, 2005. Registration cert. NR-1242-D-101-E was completed anddated June 8, 2005, however;this will not be sent out untilthe E-license is complete. Atthat time they will both be sentout together along with a coverletter. Returned from RosJones (Fees) July 19, 2005.

22 Materials Safety & Inspection Branch

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Closed Sealed Source & Device ActionsBy Date Completed for the period 10/01/2004 to 07/15/2005

For actions recorded as of Tuesday, July 26, 2005

Date Completed

Assign. #Actions

Reviewer

CompanyModel Numbers Status

06/23/2005 05-36 Ashkeboussi

1 GE InfrastructureSecurity

Validator ITMS

Amendment request toExempt License 20-23904-01E to reflect the addition of anew model to its distributionlicense as well as amendingregistration certificate NR-399-D-101-E to add the new modelon the list.1st: Nima Ashkeboussi2nd: John JankovichTo Fees June 29, 2004.ADAMS Package: ML051800435Case closed out June 23,2004, by letter to Tim Brandonenclosing Amendment 2 forLicense 20-23904-01E andamended registrationcertificate NR-399-D-101-E.

Total Completed Case(s) is 39 Totaling 46 Action(s)

23 Materials Safety & Inspection Branch