Clearance Summary
SUN FILTERS/SHIELDS received FDA 510(k) clearance under submission number K941829, sponsored by Klinger Eye Shields, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-05-17.
- Submission: K941829
- Applicant / Sponsor: Klinger Eye Shields, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 1994-05-17
Classification & Regulation
This clearance is catalogued under FDA product code HOY and 21 CFR 886.4750, within the Ophthalmic review panel as a Class I device.