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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 K130300
Device Name HEATER-COOLER UNIT HCU 40
Applicant
MAQUET CARDIOPULMONARY AG
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact HELDER A SOUSA
Correspondent
MAQUET CARDIOPULMONARY AG
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact HELDER A SOUSA
Regulation Number870.4250
Classification Product Code
DWC  
Date Received02/07/2013
Decision Date 07/01/2013
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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