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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 K091008
Device Name STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
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 Received04/09/2009
Decision Date 07/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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