Clearance Summary
HANAULUX BLUE 75 AND HANAULUX BLUE 120 received FDA 510(k) clearance under submission number K973466, sponsored by Heraeus Med 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 1997-10-24.
- Submission: K973466
- Applicant / Sponsor: Heraeus Med GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1997-10-24
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.