DYNAREX DRAIN SPONGE

Bandage, Liquid

DYNAREX CORP.

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

Pre-market Notification Details

Device IDK991694
510k NumberK991694
Device Name:DYNAREX DRAIN 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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.