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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 K092463
Device Name SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
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 Number870.4220
Classification Product Code
DTQ  
Date Received08/11/2009
Decision Date 11/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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