Clearance Summary
VETTA LIGHTWEIGHT CYCLING EYEWEAR received FDA 510(k) clearance under submission number K945683, sponsored by Shaw, Pittman, Potts & Trowbridge. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-01-05.
- Submission: K945683
- Applicant / Sponsor: Shaw, Pittman, Potts & Trowbridge
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1995-01-05
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.