Clearance Summary
APACERAM OSSICULAR PROSTHESIS received FDA 510(k) clearance under submission number K893134, sponsored by Asahi Optical Co. C/O Rosati Associates, P.C.. 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 1989-08-03.
- Submission: K893134
- Applicant / Sponsor: Asahi Optical Co. C/O Rosati Associates, P.C.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3450
- Decision date: 1989-08-03
Classification & Regulation
This clearance is catalogued under FDA product code ETB and 21 CFR 874.3450, within the Ear, Nose, Throat review panel as a Class II device.