Clearance Summary
COE-SIL received FDA 510(k) clearance under submission number K792428, sponsored by Coe Laboratories, Inc.. 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 1980-01-23.
- Submission: K792428
- Applicant / Sponsor: Coe Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1980-01-23
Classification & Regulation
This clearance is catalogued under FDA product code LDG and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.