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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 K032144
Device Name PERIFIX CATHETER CONNECTOR
Applicant
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109 -9341
Applicant Contact AMY SMITH
Correspondent
B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109 -9341
Correspondent Contact AMY SMITH
Regulation Number868.5140
Classification Product Code
CAZ  
Subsequent Product Code
BSO  
Date Received07/14/2003
Decision Date 10/01/2003
Decision Substantially Equivalent (SESE)
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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