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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Control Unit, Cardiopulmonary Bypass
510(k) Number K101046
Device Name STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
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 Number870.4300
Classification Product Code
DTX  
Date Received04/14/2010
Decision Date 12/09/2010
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
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