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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 K071358
Device Name REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
Applicant
Radiant Medical
250 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact SCOTT A WILSON
Correspondent
Radiant Medical
250 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact SCOTT A WILSON
Regulation Number870.5900
Classification Product Code
NCX  
Date Received05/15/2007
Decision Date 06/01/2007
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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