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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 K142702
Device Name Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
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 Received09/22/2014
Decision Date 12/18/2014
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
Recalls CDRH Recalls
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