Clearance Summary
DEANS DISPOSABLE T-TUBE INSERTER received FDA 510(k) clearance under submission number K924901, 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 1993-01-28.
- Submission: K924901
- 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: 1993-01-28
Classification & Regulation
This clearance is catalogued under FDA product code JYM and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.