Clearance Summary
I-GLIDE IOL IMPLANTATION AID received FDA 510(k) clearance under submission number K832939, sponsored by I For M, 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 1983-10-04.
- Submission: K832939
- Applicant / Sponsor: I For M, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 1983-10-04
Classification & Regulation
This clearance is catalogued under FDA product code KYB and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.