Clearance Summary
EXMOOR SINGLE USE MYRINGOTOMES received FDA 510(k) clearance under submission number K942745, 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 1994-09-02.
- Submission: K942745
- Applicant / Sponsor: Exmoor Plastics , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1994-09-02
Classification & Regulation
This clearance is catalogued under FDA product code LRC and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.