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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 K941916
Device Name QUEST CORONARY SINUS PERFUSION CANNULA -FRCC
Applicant
QUEST MEDICAL, INC.
one allentown pkwy.
allen,  TX  75002
Applicant Contact drew johnson
Correspondent
QUEST MEDICAL, INC.
one allentown pkwy.
allen,  TX  75002
Correspodent Contact drew johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/19/1994
Decision Date 04/06/1995
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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