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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 K262532
Device Name NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
Applicant
ICU Medical
600 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact Luis Ramirez
Correspondent
ICU Medical
600 N. Field Dr.
Lake Forest,  IL  60045
Correspondent Contact Luis Ramirez
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received07/22/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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