Clearance Summary
NASAL DORSUM received FDA 510(k) clearance under submission number K925743, sponsored by Smith & Nephew Richards, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-08-10.
- Submission: K925743
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3680
- Decision date: 1993-08-10
Classification & Regulation
This clearance is catalogued under FDA product code FZE and 21 CFR 878.3680, within the General, Plastic Surgery review panel as a Class II device.