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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 computerized behavioral therapy device for substance use disorders
De Novo Number DEN160018
Device Name reSet
Requester
pear therapeutics, inc.
745 atlantic ave.
boston,  MA  02111
Contact nandini murthy
Regulation Number882.5801
Classification Product Code
PWE  
Date Received05/16/2016
Decision Date 09/14/2017
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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