Clearance Summary
CAT. 7-EAR, NOSE & THROAT DEVICES received FDA 510(k) clearance under submission number K840311, sponsored by Imm Enterprises , 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 1984-05-09.
- Submission: K840311
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5220
- Decision date: 1984-05-09
Classification & Regulation
This clearance is catalogued under FDA product code KCP and 21 CFR 874.5220, within the Ear, Nose, Throat review panel as a Class I device.