Clearance Summary
REDON SET received FDA 510(k) clearance under submission number K001716, sponsored by Pfm Produkte Fur Die Medizin AG. 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 2000-07-19.
- Submission: K001716
- Applicant / Sponsor: Pfm Produkte Fur Die Medizin AG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2000-07-19
Classification & Regulation
This clearance is catalogued under FDA product code JCX and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.