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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 transcutaneous electrical nerve stimulator for the relief of congestion
De Novo Number DEN200006
Device Name ClearUP Sinus Relief
Requester
tivic health systems, inc.
750 menlo ave.
suite 200
menlo park,  CA  94025
Contact michael nketiah
Regulation Number874.6000
Classification Product Code
QNU  
Date Received02/07/2020
Decision Date 03/05/2021
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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