DYNAREX NON-WOVEN SPONGE

Bandage, Liquid

DYNAREX CORP.

The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Non-woven Sponge.

Pre-market Notification Details

Device IDK991695
510k NumberK991695
Device Name:DYNAREX NON-WOVEN SPONGE
ClassificationBandage, Liquid
Applicant DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster,  NY  10509
ContactJohn G Moulden
CorrespondentJohn G Moulden
DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster,  NY  10509
Product CodeKMF  
CFR Regulation Number880.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-18
Decision Date1999-07-15

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