Clearance Summary
TREBAY TOTAL RECTANGULAR HEAD received FDA 510(k) clearance under submission number K954518, sponsored by Trebay Medical Corp.. 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 1995-10-27.
- Submission: K954518
- Applicant / Sponsor: Trebay Medical Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3495
- Decision date: 1995-10-27
Classification & Regulation
This clearance is catalogued under FDA product code ETA and 21 CFR 874.3495, within the Ear, Nose, Throat review panel as a Class II device.