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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 Management, Over-The-Counter
510(k) Number K260935
Device Name Stelo Glucose Biosensor System
Applicant
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Neeta Sharma
Correspondent
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Shaun Adriano
Regulation Number862.1355
Classification Product Code
SBH  
Date Received03/20/2026
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Clinical Trials NCT04794478
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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