Clearance Summary
LEVIGATOR, KEELER PHOKO received FDA 510(k) clearance under submission number K782141, sponsored by Keeler Optical Products , 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 1979-01-26.
- Submission: K782141
- Applicant / Sponsor: Keeler Optical Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 1979-01-26
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.