BLUNT SYRINGE CANNULA

Needle, Hypodermic, Single Lumen

B. BRAUN MEDICAL, INC.

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

Pre-market Notification Details

Device IDK971924
510k NumberK971924
Device Name:BLUNT SYRINGE CANNULA
ClassificationNeedle, Hypodermic, Single Lumen
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 CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-23
Decision Date1998-09-25
Summary:summary

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