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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K102919
Device Name NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
Applicant
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Applicant Contact KATRIN SCHWENKGLENKS
Correspondent
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Correspondent Contact KATRIN SCHWENKGLENKS
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Codes
DTP   JOD  
Date Received10/01/2010
Decision Date 03/11/2011
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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