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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 combined acoustic and electrical external stimulation device for the relief of tinnitus
De Novo Number DEN210033
Device Name Lenire Tinnitus Treatment Device
Requester
neuromod devices limited
rainsford st.
dublin 8,  IE d08 r2yp
Contact fran coogan
Regulation Number874.3410
Classification Product Code
QVN  
Date Received08/18/2021
Decision Date 03/06/2023
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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