Clearance Summary
OMEGA ULTRASCAN received FDA 510(k) clearance under submission number K954911, sponsored by Gyne-Tech Instrument Corp.. 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 1996-01-24.
- Submission: K954911
- Applicant / Sponsor: Gyne-Tech Instrument Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1996-01-24
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.