Clearance Summary
DURQ/ QUALIDURA received FDA 510(k) clearance under submission number K013116, sponsored by Ever-Safety Technical Service. 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 2002-01-18.
- Submission: K013116
- Applicant / Sponsor: Ever-Safety Technical Service
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2002-01-18
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.