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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 K243942
Device Name Arctic Sun Stat Temperature Management System
Applicant
Medivance, Inc.
321 S. Taylor Ave.
Suite 200
Louisville,  CO  80027
Applicant Contact Lauren Valdes
Correspondent
Medivance, Inc.
321 S. Taylor Ave.
Suite 200
Louisville,  CO  80027
Correspondent Contact Lauren Valdes
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received12/20/2024
Decision Date 04/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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