B. BRAUN 0.2 MICRON FILTER

Syringe, Piston

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for B. Braun 0.2 Micron Filter.

Pre-market Notification Details

Device IDK052773
510k NumberK052773
Device Name:B. BRAUN 0.2 MICRON FILTER
ClassificationSyringe, Piston
Applicant B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
ContactChristine Ford
CorrespondentChristine Ford
B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown,  PA  18109 -9341
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-03
Decision Date2006-01-24
Summary:summary

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