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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 K090004
Device Name LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
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 Received01/02/2009
Decision Date 01/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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