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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, roller type
510(k) Number K131618
Device Name LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
Applicant
Terumo Cardiovascular Systems Corporation
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Applicant Contact JOHN CHESNEY
Correspondent
Terumo Cardiovascular Systems Corporation
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Correspondent Contact JOHN CHESNEY
Regulation Number870.4370
Classification Product Code
DWB  
Date Received06/03/2013
Decision Date 09/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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