Clearance Summary
VENTILATION TUBES W/ HYDROGEL COATING received FDA 510(k) clearance under submission number K923353, sponsored by Microbio-Medics, 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 1993-05-18.
- Submission: K923353
- Applicant / Sponsor: Microbio-Medics, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3880
- Decision date: 1993-05-18
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.