Clearance Summary
SUNGLASSES received FDA 510(k) clearance under submission number K910329, sponsored by Cutler & Gross Sloan Optical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1991-03-12.
- Submission: K910329
- Applicant / Sponsor: Cutler & Gross Sloan Optical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5840
- Decision date: 1991-03-12
Classification & Regulation
This clearance is catalogued under FDA product code HOI and 21 CFR 886.5840, within the Ophthalmic review panel as a Class I device.