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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion
510(k) Number K994274
Device Name QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
Applicant
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Applicant Contact MALCOLM LEWIS
Correspondent
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Correspondent Contact MALCOLM LEWIS
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
DRS   DTR   DWF   DXS   KRL  
Date Received12/20/1999
Decision Date 05/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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