Clearance Summary
EVRF SYSTEM received FDA 510(k) clearance under submission number K130283, sponsored by F Care Systems NV. 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 2013-03-07.
- Submission: K130283
- Applicant / Sponsor: F Care Systems NV
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2013-03-07
Classification & Regulation
This clearance is catalogued under FDA product code ONQ and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.