Clearance Summary
JAHN VENTILATION TUBE received FDA 510(k) clearance under submission number K900267, sponsored by Smith & Nephew Richards, 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 1990-06-14.
- Submission: K900267
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3880
- Decision date: 1990-06-14
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.