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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 K052601
FOIA Releasable 510(k) K052601
Device Name STOCKERT HEATER-COOLER SYSTEM 3T
Applicant
Sorin Group Deutschland GmbH
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
Sorin Group Deutschland GmbH
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number870.4250
Classification Product Code
DWC  
Date Received09/21/2005
Decision Date 06/06/2006
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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