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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Temperature, Cardiopulmonary Bypass
510(k) Number K071521
Device Name TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Applicant Contact MARK A BUR
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Correspondent Contact MARK A BUR
Regulation Number870.4250
Classification Product Code
DWC  
Date Received06/04/2007
Decision Date 11/21/2007
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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