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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 K131179
Device Name CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
Applicant
Thoratec Corp
23 4th Ave.
Burlington,  MA  01803
Applicant Contact YVERRE BOBAY
Correspondent
Thoratec Corp
23 4th Ave.
Burlington,  MA  01803
Correspondent Contact YVERRE BOBAY
Regulation Number870.4380
Classification Product Code
DWA  
Date Received04/25/2013
Decision Date 07/18/2013
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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