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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 K060308
Device Name COOLGARD 3000
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 Received02/09/2006
Decision Date 04/26/2006
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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