Clearance Summary
LOCATOR, FOREIGN BODY received FDA 510(k) clearance under submission number K781892, 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 1978-12-04.
- Submission: K781892
- Applicant / Sponsor: Keeler Optical Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4400
- Decision date: 1978-12-04
Classification & Regulation
This clearance is catalogued under FDA product code HPM and 21 CFR 886.4400, within the Ophthalmic review panel as a Class II device.