Clearance Summary
UNISILK received FDA 510(k) clearance under submission number K042282, sponsored by United Medical Industries Co. , Ltd.. 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 2004-12-01.
- Submission: K042282
- Applicant / Sponsor: United Medical Industries Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5030
- Decision date: 2004-12-01
Classification & Regulation
This clearance is catalogued under FDA product code GAP and 21 CFR 878.5030, within the General, Plastic Surgery review panel as a Class II device.