Clearance Summary
THE SUN BOOTH received FDA 510(k) clearance under submission number K801095, sponsored by Sun Booths , Ltd.. 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 1980-07-21.
- Submission: K801095
- Applicant / Sponsor: Sun Booths , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 1980-07-21
Classification & Regulation
This clearance is catalogued under FDA product code LEJ and 21 CFR 878.4635, within the General, Plastic Surgery review panel as a Class II device.