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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hypothermia, Intravenous, Cooling
510(k) Number K012512
Device Name SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
Applicant
Radiant Medical
250 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact ANDREW CLEELAND
Correspondent
Radiant Medical
250 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact ANDREW CLEELAND
Regulation Number870.5900
Classification Product Code
NCX  
Date Received08/06/2001
Decision Date 06/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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