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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 K083340
Device Name LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
Applicant
LEVITRONIX LLC.
45 FIRST AVE.
WALTHAM,  MA  02451
Applicant Contact SUSAN HAMANN
Correspondent
LEVITRONIX LLC.
45 FIRST AVE.
WALTHAM,  MA  02451
Correspondent Contact SUSAN HAMANN
Regulation Number870.4380
Classification Product Code
DWA  
Date Received11/12/2008
Decision Date 11/26/2008
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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