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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 vestibular stimulator for headache
De Novo Number DEN170023
Device Name ThermoNeuroModulation Device, TNM Device
Requester
scion neurostim, llc
3105 cone manor ln.
raleigh,  NC  27613
Contact robert black
Regulation Number882.5893
Classification Product Code
QAR  
Date Received04/17/2017
Decision Date 03/26/2018
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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