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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 K063829
Device Name THERMOGARD THERMAL REGULATION SYSTEM
Applicant
ALSIUS CORP.
15770 LAGUNA CANYON, SUITE 150
IRVINE,  CA  92618
Applicant Contact KENNETH A COLLINS
Correspondent
ALSIUS CORP.
15770 LAGUNA CANYON, SUITE 150
IRVINE,  CA  92618
Correspondent Contact KENNETH A COLLINS
Regulation Number870.5900
Classification Product Code
NCX  
Date Received12/26/2006
Decision Date 01/22/2007
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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