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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 K910005
Device Name VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM
Original Applicant
MED INSTITUTE, INC.
p.o. box 2402
west lafayette,  IN  47906
Original Contact neal e fearnot
Regulation Number880.5965
Classification Product Code
LJT  
Date Received01/02/1991
Decision Date 03/13/1991
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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