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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
Recalls CDRH Recalls
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