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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 K925049
Device Name QUEST HEART INSULATION PAD
Original Applicant
QUEST MEDICAL, INC.
4103 billy mitchell dr.
dallas,  TX  75244
Original Contact drew johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/06/1992
Decision Date 02/01/1994
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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