Clearance Summary
NON-PRESCRIPTION SUNGLASSES received FDA 510(k) clearance under submission number K940806, sponsored by Top Fashion Optical & Sunglasses. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-04-11.
- Submission: K940806
- Applicant / Sponsor: Top Fashion Optical & Sunglasses
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1994-04-11
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.