Acclarent Aera Eustachian Tube Balloon Dilation System— 510(k) DEN150056
UnknownAcclarent, Inc.
FDA 510(k) clearance DEN150056 for Acclarent Aera Eustachian Tube Balloon Dilation System, Unknown on 2016-09-16. Applicant: Acclarent, Inc.. Device class: 2.
Clearance details
- Applicant
- Acclarent, Inc.
- Product code
- Code PNZ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4180
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Rmenlo Park, CA, US
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