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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 K955818
Device Name FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER
Original Applicant
QUEST MEDICAL, INC.
one allentown pkwy.
allen,  TX  75002
Original Contact krista oakes
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/26/1995
Decision Date 03/26/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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