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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 monitoring system for non-intensive diabetes management
510(k) Number K182041
Device Name Dexcom G6 Glucose Program Continuous Glucose Monitoring System
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Luke Olson
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Luke Olson
Regulation Number862.1355
Classification Product Code
Date Received07/30/2018
Decision Date 10/26/2018
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 No