Clearance Summary
GELENDER VACUUM FIXATION RING SYS received FDA 510(k) clearance under submission number K832912, sponsored by Miami Eye Technology, 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 1984-01-10.
- Submission: K832912
- Applicant / Sponsor: Miami Eye Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1984-01-10
Classification & Regulation
This clearance is catalogued under FDA product code HNH and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.