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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 K994111
Device Name CELSITE, MODELS ST401L, ST405L
Applicant
B. Braun/Mcgaw
901 Marcon Blvd.
Allentown,  PA  18103 -9341
Applicant Contact VALERIE LEWIS
Correspondent
B. Braun/Mcgaw
901 Marcon Blvd.
Allentown,  PA  18103 -9341
Correspondent Contact VALERIE LEWIS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/06/1999
Decision Date 01/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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