Clearance Summary
MODEL 6/01 UV-B FIXTURE received FDA 510(k) clearance under submission number K904425, sponsored by Strato-Ray Co.. 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 1990-11-21.
- Submission: K904425
- Applicant / Sponsor: Strato-Ray Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 1990-11-21
Classification & Regulation
This clearance is catalogued under FDA product code FTC and 21 CFR 878.4630, within the General, Plastic Surgery review panel as a Class II device.