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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
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