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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 K071318
Device Name MODIFICATION TO: STOCKERT S5 SYSTEM
Original Applicant
SORIN GROUP DEUTSCHLAND GMBH
49 plain street
north attleboro,  MA  02760
Original Contact rosina robinson
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received05/10/2007
Decision Date 07/06/2007
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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