Clearance Summary
EYE SURGERY INSTRUMENT received FDA 510(k) clearance under submission number K840101, sponsored by Truline Instruments, 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 1984-03-16.
- Submission: K840101
- Applicant / Sponsor: Truline Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1984-03-16
Classification & Regulation
This clearance is catalogued under FDA product code HOB and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.