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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 K002577
Device Name ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS
Applicant
MEDIVANCE, INC.
500 S. ARTHUR AVENUE, STE 100
LOUISVILLE,  CO  80027
Applicant Contact ROBERT A KLINE
Correspondent
MEDIVANCE, INC.
500 S. ARTHUR AVENUE, STE 100
LOUISVILLE,  CO  80027
Correspondent Contact ROBERT A KLINE
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received08/18/2000
Decision Date 10/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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