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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 K924748
Device Name VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P
Original Applicant
p.o. box 2402
west lafayette,  IN  47906
Original Contact neal e fearnot
Regulation Number880.5965
Classification Product Code
Date Received09/22/1992
Decision Date 07/28/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls