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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 K132202
Device Name DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
Applicant
ENTHERMICS MEDICAL SYSTEMS, INC.
WEST 164 NORTH 9221 WATER ST.
MENOMONEE FALLS,  WI  53051
Applicant Contact ADAM VAN ESSEN
Correspondent
ENTHERMICS MEDICAL SYSTEMS, INC.
WEST 164 NORTH 9221 WATER ST.
MENOMONEE FALLS,  WI  53051
Correspondent Contact ADAM VAN ESSEN
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received07/16/2013
Decision Date 12/06/2013
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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