Clearance Summary
OTOLOGICAL VENTILATION TUBES received FDA 510(k) clearance under submission number K802638, sponsored by Santa Barbara Medco, 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 1980-11-12.
- Submission: K802638
- Applicant / Sponsor: Santa Barbara Medco, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3880
- Decision date: 1980-11-12
Classification & Regulation
This clearance is catalogued under FDA product code ETD and 21 CFR 874.3880, within the Ear, Nose, Throat review panel as a Class II device.