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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 K010338
Device Name ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
Applicant
MEDIVANCE, INC.
500 S. ARTHUR AVENUE, STE 100
LOUISVILLE,  CO  80027
Applicant Contact LYNNE ARONSON
Correspondent
MEDIVANCE, INC.
500 S. ARTHUR AVENUE, STE 100
LOUISVILLE,  CO  80027
Correspondent Contact LYNNE ARONSON
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received02/05/2001
Decision Date 03/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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