PRONTOSAN WOUND IRRIGATION SOLUTION

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 Wound Irrigation Solution.

Pre-market Notification Details

Device IDK110744
510k NumberK110744
Device Name:PRONTOSAN WOUND IRRIGATION SOLUTION
ClassificationDressing, Wound, Drug
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactNancy Skocypec
CorrespondentNancy Skocypec
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 Received2011-03-17
Decision Date2011-04-06
Summary:summary

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