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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Temperature, Cardiopulmonary Bypass
510(k) Number K102147
Device Name CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
Applicant
CARDIOQUIP LLP
3827 OLD COLLEGE RD
BRYAN,  TX  77801
Applicant Contact DOUGLAS PLATT
Correspondent
CARDIOQUIP LLP
3827 OLD COLLEGE RD
BRYAN,  TX  77801
Correspondent Contact DOUGLAS PLATT
Regulation Number870.4250
Classification Product Code
DWC  
Date Received07/30/2010
Decision Date 11/19/2010
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
Recalls CDRH Recalls
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