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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 K951088
Device Name QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS
Original Applicant
QUEST MEDICAL, INC.
one allentown pkwy.
allen,  TX  75002
Original Contact drew johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/09/1995
Decision Date 06/14/1995
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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