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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K112229
Device Name SARN CENTRIFUGAL PUMP
Applicant
Terumo Cardiovascular Systems
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact REBECCA ANDERSEN
Correspondent
Terumo Cardiovascular Systems
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact REBECCA ANDERSEN
Regulation Number870.4360
Classification Product Code
KFM  
Date Received08/03/2011
Decision Date 12/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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