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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 K072080
Device Name NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
Applicant
Smiths Medical Asd, Inc.
160 Weymouth St.
Rockland,  MA  02370
Applicant Contact CYNTHIA ENGELHARDT
Correspondent
Smiths Medical Asd, Inc.
160 Weymouth St.
Rockland,  MA  02370
Correspondent Contact CYNTHIA ENGELHARDT
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received07/30/2007
Decision Date 06/02/2008
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
Recalls CDRH Recalls
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