Clearance Summary
Ergoline Sunrise 7200 Hybrid Technology received FDA 510(k) clearance under submission number K183539, sponsored by Jk-Holding GmbH. 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 2019-04-08.
- Submission: K183539
- Applicant / Sponsor: Jk-Holding GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 2019-04-08
Classification & Regulation
This clearance is catalogued under FDA product code LEJ and 21 CFR 878.4635, within the General, Plastic Surgery review panel as a Class II device.