BRAUN PREFILLED SYRINGE

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

B. BRAUN MEDICAL, INC.

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

Pre-market Notification Details

Device IDK970736
510k NumberK970736
Device Name:BRAUN PREFILLED SYRINGE
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem,  PA  18018
ContactMark S Alsberge
CorrespondentMark S Alsberge
B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem,  PA  18018
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-28
Decision Date1998-12-16
Summary:summary

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