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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 K864349
Device Name MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT
Applicant
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Applicant Contact JOSEPH KICEINA
Correspondent
C.R. BARD, INC.
111 SPRING ST.
MURRAY HILL,  NJ  07974
Correspondent Contact JOSEPH KICEINA
Regulation Number880.5965
Classification Product Code
LJT  
Date Received11/04/1986
Decision Date 02/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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