Clearance Summary
Bonebridge received FDA 510(k) clearance under submission number DEN170009, sponsored by Med-El Elektromedizinische Geraete GmbH. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2018-07-20.
- Submission: DEN170009
- Applicant / Sponsor: Med-El Elektromedizinische Geraete GmbH
- Clearance pathway: Direct
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3340
- Decision date: 2018-07-20
Classification & Regulation
This clearance is catalogued under FDA product code PFO and 21 CFR 874.3340, within the Ear, Nose, Throat review panel as a Class II device.