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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 K103762
Device Name SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
Applicant
Sorin Group Deutschland GmbH
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSON, RN, MED, RAC
Correspondent
Sorin Group Deutschland GmbH
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSON, RN, MED, RAC
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received12/23/2010
Decision Date 01/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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