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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, pump speed, cardiopulmonary bypass
510(k) Number K112225
Device Name SORIN CENTRIFUGAL PUMP 5 (CP5)
Applicant
SORIN GROUP DEUTSCHLAND GMBH
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
SORIN GROUP DEUTSCHLAND GMBH
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number870.4380
Classification Product Code
DWA  
Date Received08/03/2011
Decision Date 09/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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