Clearance Summary
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) received FDA 510(k) clearance under submission number K963899, sponsored by Exmoor Plastics , Ltd.. 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 1997-08-22.
- Submission: K963899
- Applicant / Sponsor: Exmoor Plastics , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3495
- Decision date: 1997-08-22
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.