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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 K002366
Device Name QUEST MPS BACK-UP SYSYEM
Applicant
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Applicant Contact DOUG BRYAN
Correspondent
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Correspondent Contact DOUG BRYAN
Regulation Number870.4210
Classification Product Code
DWF  
Subsequent Product Codes
DRS   DTR   DXS   KRL  
Date Received07/27/2000
Decision Date 09/18/2000
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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