Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456;...

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Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Transcript of Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456;...

Page 1: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 2: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 3: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 4: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 5: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 6: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 7: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 8: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 9: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 10: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 11: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 12: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 13: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 14: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 15: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 16: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 17: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 18: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 19: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 20: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 21: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 22: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 23: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 24: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 25: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 26: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 27: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 28: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 29: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 30: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 31: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) Self Administration Market Research

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 32: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 33: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 34: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 35: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 36: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 37: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 38: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 39: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 40: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 41: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 42: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 43: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 44: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 45: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 46: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 47: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 48: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 49: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 50: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 51: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 52: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 53: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

(b) (4) YPSOMED Selfcare Solutions

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 54: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 55: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 56: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 57: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 58: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 59: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018

Questions? Contact FDA/CDRH/OCE/DID at [email protected] (301) 796-8118

Page 60: Questions? Contact FDA/CDRH/OCE/DID at CDRH …Records processed under FOIA Request # 2017-10456; Released by CDRH on 04-30-2018 Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov

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Questions? Contact FDA/CDRH/OCE/DID at CDRH … · 3985 Sagamore Parkway North, Suite 220 . Lafayette, IN 47904 . FDA Registration #: 3004555298 . Sterilization Site: BeamOne LLC

Questions? Contact FDA/CDRH/OCE/DID at CDRH … · 3985 Sagamore Parkway North, Suite 220 . Lafayette, IN 47904 . FDA Registration #: 3004555298 . Sterilization Site: BeamOne LLC

DHHS / FDA / CDRH 1 FDA Summary CryoLife BioGlue P010003 Lead FDA Reviewer Lisa Kennell.

DHHS / FDA / CDRH 1 FDA Summary CryoLife BioGlue P010003 Lead FDA Reviewer Lisa Kennell.

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Scott Colburn, CAPT USPHS Director, FDA/CDRH Standards … Documents/Meetings...FDA Policy on Standards “Policy regarding the development and use of ... International Medical Device

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Medical Device Development Tools: FDA CDRH Pilot Program Kathryn O‘Callaghan Senior Science Health Advisor Office of the Center Director FDA CDRH MDIC.

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Questions? Contact FDA/CDRH/OCE/DID at CDRH … · Records processed under FOIA # 2014-2621; Released by CDRH on 11-13-2015 Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@FDA.HHS.GOV

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1 Statistical Review DRAFT Barbara Krasnicka, Ph.D. FDA, CDRH Division of Biostatistics.

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Questions?Contact Records processed FDA/CDRH/OCE/DID under ... · bath is heated with both heaters or, 1500 watts of heat. The water temperature will increase at a rate of approximately

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Welcome to today's FDA/CDRH Webinar · 1 Welcome to today’s FDA/CDRH Webinar Thank you for your patience while we register all of today’s participants. If you have not connected

Welcome to today's FDA/CDRH Webinar · 1 Welcome to today’s FDA/CDRH Webinar Thank you for your patience while we register all of today’s participants. If you have not connected

Introduction to US FDA CDRH Regulations, 510(k) to US FDA CDRH Regulations, 510(k) Do-Hyun Kim, Ph.D, Ph.D CEO, BT Solutions, Inc. South Korea CEO, Solutions 4BT, LLC, USA The Transformation

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processed under FOIA Request #2015-4874; Released by CDRH on 07-25-2016. Questions? Contact FDA/CDRH/OCE/DID at CDRH-FOISTATUS@fda.hhs.gov or call 301-796-8118. " Loads and primes

processed under FOIA Request #2015-4874; Released by CDRH on 07-25-2016. Questions? Contact FDA/CDRH/OCE/DID at [email protected] or call 301-796-8118. " Loads and primes

Questions? Contact FDA/CDRH/OCE/DID at CDRH · PDF filethe STERRAD®100S sterilizer. ... Hold Time. testing which supports ... Expiration Date: December 31, 2013 See PRA Statement

Questions? Contact FDA/CDRH/OCE/DID at CDRH · PDF filethe STERRAD®100S sterilizer. ... Hold Time. testing which supports ... Expiration Date: December 31, 2013 See PRA Statement

Questions? Contact FDA/CDRH/OCE/DID at CDRH … · 2016-08-03 · 007 device to sale by or on the order of a physician or hospital ($1" howmedica inc orthopaedics division " ''°

Questions? Contact FDA/CDRH/OCE/DID at CDRH … · 2016-08-03 · 007 device to sale by or on the order of a physician or hospital ($1" howmedica inc orthopaedics division " ''°

Questions? Contact FDA/CDRH/OCE/DID at CDRH … · User Fee Payment ID Number FDA Submission Document Number (if known) 513(g) Notice of Completion Amendment to PDP Regular (180 day)

Questions? Contact FDA/CDRH/OCE/DID at CDRH … · User Fee Payment ID Number FDA Submission Document Number (if known) 513(g) Notice of Completion Amendment to PDP Regular (180 day)

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Welcome to today’s FDA/CDRH Webinar · Welcome to today’s FDA/CDRH Webinar Thank you for your patience while we register all of today’s participants. If you have not connected

Digital Health Initiatives at FDA · Digital Health Initiatives at FDA Heather Agler, Ph.D. Senior Science Health Advisor Innovation Program, EMCM Office of the Center Director/CDRH/FDA

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