Clearance Summary
EXMOOR SILICONE RUBBER SHEET received FDA 510(k) clearance under submission number K911503, 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 1991-11-19.
- Submission: K911503
- Applicant / Sponsor: Exmoor Plastics , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 1991-11-19
Classification & Regulation
This clearance is catalogued under FDA product code KHJ and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.