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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K832475
Device Name AXIOM PERFUSSION CANNULA
Original Applicant
AXIOM MEDICAL, INC.
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/26/1983
Decision Date 10/19/1983
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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