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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 oropharyngeal electrical stimulator
De Novo Number DEN220025
Device Name Phagenyx System
Phagenesis Limited
unit 18, enterprise house
pencroft ay, manchester science park
manchester,  GB m15 65e
Contact conor mulrooney
Regulation Number874.5950
Classification Product Code
Date Received04/19/2022
Decision Date 09/16/2022
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Reclassification Order Reclassification Order
Type Direct