Clearance Summary
TURBINATE NASAL SPLINT received FDA 510(k) clearance under submission number K921202, 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 1992-07-23.
- Submission: K921202
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4780
- Decision date: 1992-07-23
Classification & Regulation
This clearance is catalogued under FDA product code LYA and 21 CFR 874.4780, within the Ear, Nose, Throat review panel as a Class I device.