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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K060939
Device Name RANGER IRRIGATION FLUID WARMING 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 Number880.5725
Classification Product Code
LGZ  
Date Received04/06/2006
Decision Date 06/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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