Clearance Summary
FLUORESCENT SUN LAMP FIXTURE received FDA 510(k) clearance under submission number K802291, 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 1980-10-31.
- Submission: K802291
- Applicant / Sponsor: Strato-Ray Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1980-10-31
Classification & Regulation
This clearance is catalogued under FDA product code HJE and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.