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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 K041686
FOIA Releasable 510(k) K041686
Device Name BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
Applicant
Arizant Healthcare, Inc.
10393 W. 70th St.
Eden Prairie,  MN  55344
Applicant Contact DAVID WESTLIN
Correspondent
Arizant Healthcare, Inc.
10393 W. 70th St.
Eden Prairie,  MN  55344
Correspondent Contact DAVID WESTLIN
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/22/2004
Decision Date 06/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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