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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K962230
Device Name CELSITE PORT WITH PRECONNECTED CATHETER
Applicant
B.Braun Medical, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B.Braun Medical, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/10/1996
Decision Date 12/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
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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