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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Insulin Bolus
510(k) Number K243273
Device Name CeQur Simplicity™ On-Demand Insulin Delivery System
Applicant
Cequr SA
Ebenaustrasse 10
Horw Luzern,  CH 6048
Applicant Contact Michael Simpson
Correspondent
Cequr SA
Ebenaustrasse 10
Horw Luzern,  CH 6048
Correspondent Contact Michael Simpson
Regulation Number880.5725
Classification Product Code
OPP  
Subsequent Product Code
LZG  
Date Received10/16/2024
Decision Date 11/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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