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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
Applicant Contact KEN COLLINS
Correspondent
Alsius Corp.
15770 Laguna Canyon, Suite 150
Irvine,  CA  92618
Correspondent Contact KEN COLLINS
Regulation Number870.5900
Classification Product Code
NCX  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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