Clearance Summary
CUI RHINOPLASTY IMPLANTS received FDA 510(k) clearance under submission number K853945, sponsored by Cox-Uphuff Intl.. 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 1985-10-18.
- Submission: K853945
- Applicant / Sponsor: Cox-Uphuff Intl.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3680
- Decision date: 1985-10-18
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.