Clearance Summary
SUNSHADES, ACRYLIC LENSES, SILVER COATED #HX-602 received FDA 510(k) clearance under submission number K913686, sponsored by Tel-Time Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1992-02-11.
- Submission: K913686
- Applicant / Sponsor: Tel-Time Products
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1992-02-11
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.