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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K962696
Device Name PERIFIX PEDIATRIC EPIDURAL KIT
Applicant
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received07/11/1996
Decision Date 04/03/1997
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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