Clearance Summary
UM-150A received FDA 510(k) clearance under submission number K981908, sponsored by Umeco Union Medical Engineering. 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 1998-08-05.
- Submission: K981908
- Applicant / Sponsor: Umeco Union Medical Engineering
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1998-08-05
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.