Clearance Summary
BAHA CORDELLE II received FDA 510(k) clearance under submission number K080363, sponsored by Cochlear Bone Anchored Systems AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2008-04-10.
- Submission: K080363
- Applicant / Sponsor: Cochlear Bone Anchored Systems AB
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3302
- Decision date: 2008-04-10
Classification & Regulation
This clearance is catalogued under FDA product code MAH and 21 CFR 874.3302, within the Ear, Nose, Throat review panel as a Class II device.