Clearance Summary
ARTIFICIAL SCLERAL SHELL received FDA 510(k) clearance under submission number K904961, sponsored by Midwest Eye Laboratories, 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 1991-08-30.
- Submission: K904961
- Applicant / Sponsor: Midwest Eye Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3800
- Decision date: 1991-08-30
Classification & Regulation
This clearance is catalogued under FDA product code HQT and 21 CFR 886.3800, within the Ophthalmic review panel as a Class II device.