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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 K161602
Device Name Arctic Sun Temperature Management System
Applicant
Medivance, Inc.
321 S. Taylor Ave.
Suite 200
Louisville,  CO  80027
Applicant Contact Stacci Cronk
Correspondent
Medivance, Inc.
321 S. Taylor Ave.
Suite 200
Louisville,  CO  80027
Correspondent Contact Stacci Cronk
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/09/2016
Decision Date 09/02/2016
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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