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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 (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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