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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 K082217
Device Name RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
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 Number880.5725
Classification Product Code
LGZ  
Date Received08/06/2008
Decision Date 10/06/2008
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
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