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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 continuous glucose monitor secondary display
De Novo Number DEN140038
Device Name Dexcom Share Direct Secondary Displays
Requester
dexcom, inc.
6340 sequence drive
san diego,  CA  92121
Contact andrew k balo
Regulation Number862.1350
Classification Product Code
PJT  
Date Received12/15/2014
Decision Date 01/23/2015
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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