Clearance Summary
TITAN AIR SPECTACLE FRAME received FDA 510(k) clearance under submission number K896350, sponsored by Acces Intl. Eyewear. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1989-12-18.
- Submission: K896350
- Applicant / Sponsor: Acces Intl. Eyewear
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3300
- Decision date: 1989-12-18
Classification & Regulation
This clearance is catalogued under FDA product code HQJ and 21 CFR 886.3300, within the Ophthalmic review panel as a Class II device.