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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
Original Applicant
ALSIUS CORP.
15770 laguna canyon, suite 150
irvine,  CA  92618
Original 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 General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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