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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 K260988
Device Name °M Warmer System with °M Station
Applicant
Mequ A/S
Fruebjergvej 3
Copenhagen/Kobenhavn,  DK 2100
Applicant Contact Lene Margrete Moesby
Correspondent
Mequ A/S
Fruebjergvej 3
Copenhagen/Kobenhavn,  DK 2100
Correspondent Contact Lene Margrete Moesby
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Code
BSB  
Date Received03/25/2026
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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