Clearance Summary
MR-III received FDA 510(k) clearance under submission number K002261, sponsored by Smith & Nephew, Inc.. 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 2000-10-23.
- Submission: K002261
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 2000-10-23
Classification & Regulation
This clearance is catalogued under FDA product code GAS and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.