Report - 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION ... · Lot 1 Lot 2 Lot 3 Pos Neg Pos Neg Pos Neg 0 Neg 0 60 0 60 0 60 2.5 -75 0 60 0 60 0 60 5 -50 0 60 0 60 0 60 7.5 -25 10

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