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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
Applicant
Med Institute, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Applicant Contact NEAL E FEARNOT
Correspondent
Med Institute, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Correspondent Contact NEAL E FEARNOT
Regulation Number880.5965
Classification Product Code
LJT  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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