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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
Applicant
AXIOM MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AXIOM MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
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 Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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