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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K201984
Device Name MPS 3 ND Myocardial Protection System
Applicant
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Applicant Contact Tosan Eweka
Correspondent
Quest Medical, Inc.
One Allentown Pkwy.
Allen,  TX  75002
Correspondent Contact Tosan Eweka
Regulation Number870.4240
Classification Product Code
DTR  
Date Received07/17/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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