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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 K950814
Device Name QUEST ANTEGRADE CARDIOPLEGIA CANNULA
Original Applicant
QUEST MEDICAL, INC.
one allentown pkwy.
allen,  TX  75002
Original Contact drew johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/22/1995
Decision Date 05/25/1995
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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