Clearance Summary
CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER received FDA 510(k) clearance under submission number K874276, 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 1987-12-02.
- Submission: K874276
- Applicant / Sponsor: Cox-Uphuff Intl.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1987-12-02
Classification & Regulation
This clearance is catalogued under FDA product code FZW and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.