PERIFIX PEDIATRIC EPIDURAL KIT

Anesthesia Conduction Kit

B. BRAUN MEDICAL, INC.

The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Perifix Pediatric Epidural Kit.

Pre-market Notification Details

Device IDK962696
510k NumberK962696
Device Name:PERIFIX PEDIATRIC EPIDURAL KIT
ClassificationAnesthesia Conduction Kit
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 CodeCAZ  
CFR Regulation Number868.5140 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-11
Decision Date1997-04-03
Summary:summary

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