Clearance Summary
THE DENVER SPLINT received FDA 510(k) clearance under submission number K791681, sponsored by Xomed, 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 1979-10-22.
- Submission: K791681
- Applicant / Sponsor: Xomed, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5800
- Decision date: 1979-10-22
Classification & Regulation
This clearance is catalogued under FDA product code EPP and 21 CFR 874.5800, within the Ear, Nose, Throat review panel as a Class I device.