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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 K192787
Device Name Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
Applicant
Dexcom, Inc.
6310 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Bryan Osborne
Correspondent
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Bryan Osborne
Regulation Number862.1355
Classification Product Code
QDK  
Date Received09/30/2019
Decision Date 10/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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