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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 K071341
Device Name MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
Applicant
Medivance, Inc.
1172 Century Dr., Suite 240
Louisville,  CO  80027
Applicant Contact LYNNE ARONSON
Correspondent
Medivance, Inc.
1172 Century Dr., Suite 240
Louisville,  CO  80027
Correspondent Contact LYNNE ARONSON
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received05/14/2007
Decision Date 08/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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