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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
Original Applicant
15770 laguna canyon, suite 150
irvine,  CA  92618
Original Contact ken collins
Regulation Number870.5900
Classification Product Code
Date Received12/26/2001
Decision Date 08/01/2003
Decision se - with limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls