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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 K014241
Device Name COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
Applicant
ALSIUS CORP.
15770 laguna canyon, suite 150
irvine,  CA  92618
Contact ken collins
Regulation Number870.5900
Classification Product Code
NCX  
Date Received12/26/2001
Decision Date 08/01/2003
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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