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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 suction anti-choking device as a second-line treatment
De Novo Number DEN250012
Device Name LifeVac
Requester
lifevac, llc
110 lake ave. s., suite 35
nesconset,  NY  11767
Contact arthur lih
Regulation Number874.5400
Classification Product Code
QXN  
Date Received04/11/2025
Decision Date 03/04/2026
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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