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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
Original Applicant
C.R. BARD, INC.
111 spring st.
murray hill,  NJ  07974
Original 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
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