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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 K200225
Device Name Arctic Sun Stat Temperature Management System
Applicant
Medivance, Inc.
321 South Taylor Ave, Suite 200
Louisville,  CO  80027
Applicant Contact Jacquelyn Borinski
Correspondent
Medivance, Inc.
321 South Taylor Ave, Suite 200
Louisville,  CO  80027
Correspondent Contact Jacquelyn Borinski
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received01/30/2020
Decision Date 02/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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