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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 K053645
FOIA Releasable 510(k) K053645
Device Name MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
Applicant
ARIZANT HEALTHCARE INC.
10393 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Applicant Contact DAVID WESTLIN
Correspondent
ARIZANT HEALTHCARE INC.
10393 WEST 70TH ST.
EDEN PRAIRIE,  MN  55344
Correspondent Contact DAVID WESTLIN
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received12/30/2005
Decision Date 03/09/2006
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
Recalls CDRH Recalls
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