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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 eustachian tube balloon dilation device
De Novo Number DEN150056
Device Name Acclarent Aera Eustachian Tube Balloon Dilation System
Requester
acclarent, inc.
1525-b o'brien dr.
rmenlo park,  CA  94025
Contact james patrick garvey
Regulation Number874.4180
Classification Product Code
PNZ  
Date Received12/07/2015
Decision Date 09/16/2016
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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