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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 K832917
Device Name PORT-A-CATH
Original Applicant
Regulation Number880.5965
Classification Product Code
Date Received08/29/1983
Decision Date 12/28/1983
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No