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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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