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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 K831330
Device Name UNIVERSAL CORONARY CANNULA
Original Applicant
POSSIS MEDICAL, INC.
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/25/1983
Decision Date 08/10/1983
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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