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U.S. Department of Health and Human Services

Devices@FDA
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Device Classification Name Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
510(k) Number K241335
Device Name Eversense 365 Continuous Glucose Monitoring (CGM) System
Applicant
Senseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown,  MD  20876
Applicant Contact Mukul Jain
Correspondent
Senseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown,  MD  20876
Correspondent Contact Mukul Jain
Classification Product Code
SBA  
Date Received05/13/2024
Decision Date 09/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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