Clearance Summary
GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE received FDA 510(k) clearance under submission number K884043, sponsored by Grieshaber & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-11-16.
- Submission: K884043
- Applicant / Sponsor: Grieshaber & Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1988-11-16
Classification & Regulation
This clearance is catalogued under FDA product code HQE and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.