Clearance Summary
BIOGLASS OSSICULAR RECONSTRUCTION PROSTH received FDA 510(k) clearance under submission number K843461, sponsored by American Biomaterials Corp.. 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 1985-01-09.
- Submission: K843461
- Applicant / Sponsor: American Biomaterials Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3495
- Decision date: 1985-01-09
Classification & Regulation
This clearance is catalogued under FDA product code ETA and 21 CFR 874.3495, within the Ear, Nose, Throat review panel as a Class II device.