PRONTOSAN ANTIMICROBIAL WOUND GEL

Dressing, Wound, Drug

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Prontosan Antimicrobial Wound Gel.

Pre-market Notification Details

Device IDK101882
510k NumberK101882
Device Name:PRONTOSAN ANTIMICROBIAL WOUND GEL
ClassificationDressing, Wound, Drug
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactMatthew J Homa
CorrespondentMatthew J Homa
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2010-07-06
Decision Date2010-11-03
Summary:summary

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