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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
510(k) Number K261359
Device Name Stelo Glucose Biosensor System
Applicant
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Ginny Hu
Correspondent
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Anthony Hardcastle
Regulation Number862.1355
Classification Product Code
SAF  
Subsequent Product Code
KGX  
Date Received04/24/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Clinical Trials NCT04794478
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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