Clearance Summary
'EXMOOR' SHAH SILICONE DISCS received FDA 510(k) clearance under submission number K864934, 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 1987-01-28.
- Submission: K864934
- Applicant / Sponsor: Exmoor Plastics , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5800
- Decision date: 1987-01-28
Classification & Regulation
This clearance is catalogued under FDA product code EPP and 21 CFR 874.5800, within the Ear, Nose, Throat review panel as a Class I device.