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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 K132166
Device Name VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
Applicant
MAQUET CARDIOPULMONARY AG
KEHLER STRASSE 31
RASTATT,  DE 76437
Applicant Contact INGRID RICHTER
Correspondent
MAQUET CARDIOPULMONARY AG
KEHLER STRASSE 31
RASTATT,  DE 76437
Correspondent Contact INGRID RICHTER
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Codes
DTP   JOD  
Date Received07/12/2013
Decision Date 10/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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