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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 thermal system for insomnia
De Novo Number DEN140032
Device Name Cereve Sleep System
Requester
cereve, inc.
333 allegheny ave., 2nd floor north
oakmont,  PA  15139
Contact eric nofzinger
Regulation Number882.5700
Classification Product Code
PLU  
Date Received10/20/2014
Decision Date 05/13/2016
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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