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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 K912423
Device Name VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112
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 Received05/31/1991
Decision Date 07/30/1991
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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