Clearance Summary
SUN BED BY VERRE ET QUARTZ UVA-FRANCE received FDA 510(k) clearance under submission number K833229, sponsored by H & M Douglas Enterprises, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-01-27.
- Submission: K833229
- Applicant / Sponsor: H & M Douglas Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4445
- Decision date: 1984-01-27
Classification & Regulation
This clearance is catalogued under FDA product code FTZ and 21 CFR 886.4445, within the Ophthalmic review panel as a Class I device.