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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K102726
Device Name CARDIOHELP SYSTEM
Applicant
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Applicant Contact ROLAND JEHLE
Correspondent
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Correspondent Contact ROLAND JEHLE
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received09/21/2010
Decision Date 04/04/2011
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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