Clearance Summary
CHROMOPHARE F 628 AND F 528 received FDA 510(k) clearance under submission number K120392, sponsored by Berchtold GmbH & Co. KG. 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 2012-02-16.
- Submission: K120392
- Applicant / Sponsor: Berchtold GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 2012-02-16
Classification & Regulation
This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.