Clearance Summary
600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L received FDA 510(k) clearance under submission number K853394, sponsored by Interlab(Electromechanical). 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 1985-09-13.
- Submission: K853394
- Applicant / Sponsor: Interlab(Electromechanical)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4630
- Decision date: 1985-09-13
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.