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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 K060865
FOIA Releasable 510(k) K060865
Device Name BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
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 Received03/30/2006
Decision Date 04/24/2006
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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