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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 K072234
Device Name THERMOGARD XP THERMAL REGULATION SYSTEM
Applicant
Alsius Corp.
15770 Laguna Canyon Rd.
Suite 150
Irvine,  CA  92618
Applicant Contact KENNETH A COLLINS
Correspondent
Alsius Corp.
15770 Laguna Canyon Rd.
Suite 150
Irvine,  CA  92618
Correspondent Contact KENNETH A COLLINS
Regulation Number870.5900
Classification Product Code
NCX  
Date Received08/10/2007
Decision Date 08/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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