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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 K072234
Device Name THERMOGARD XP THERMAL REGULATION SYSTEM
Original Applicant
ALSIUS CORP.
15770 laguna canyon rd
suite 150
irvine,  CA  92618
Original Contact kenneth a collins
Regulation Number870.5900
Classification Product Code
NCX  
Date Received08/10/2007
Decision Date 08/23/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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