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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 K993024
Device Name CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
Applicant
B. Braun of America, Inc.
901 Marcon Blvd.
Allentown,  PA  18103
Applicant Contact MARK S ALSBERGE
Correspondent
B. Braun of America, Inc.
901 Marcon Blvd.
Allentown,  PA  18103
Correspondent Contact MARK S ALSBERGE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/09/1999
Decision Date 03/13/2000
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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