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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name integrated continuous glucose monitoring system, factory calibrated
De Novo Number DEN170088
Device Name Dexcom G6 Continuous Glucose Monitoring System
Requester
dexcom, inc.
6340 sequence dr
san diego,  CA  92121
Contact neeta sharma
Regulation Number862.1355
Classification Product Code
QBJ  
Date Received12/08/2017
Decision Date 03/27/2018
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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