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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, thermal regulating
510(k) Number K101092
Device Name ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
Applicant
MEDIVANCE, INC.
321 SOUTH TAYLOR AVE, STE 200
LOUISVILLE,  CO  80027
Applicant Contact LYNNE ARONSON
Correspondent
MEDIVANCE, INC.
321 SOUTH TAYLOR AVE, STE 200
LOUISVILLE,  CO  80027
Correspondent Contact LYNNE ARONSON
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received04/20/2010
Decision Date 07/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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