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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 K033623
Device Name CELSIUS CONTROL SYSTEM
Original Applicant
INNERCOOL THERAPIES, INC.
3931 sorrento valley blvd.
san diego,  CA  92121
Original Contact steve reitzler
Regulation Number870.5900
Classification Product Code
NCX  
Date Received11/18/2003
Decision Date 05/21/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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