Clearance Summary
LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT received FDA 510(k) clearance under submission number K873578, sponsored by Oculo-Plastik Reg'D. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-11-02.
- Submission: K873578
- Applicant / Sponsor: Oculo-Plastik Reg'D
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3320
- Decision date: 1987-11-02
Classification & Regulation
This clearance is catalogued under FDA product code HPZ and 21 CFR 886.3320, within the Ophthalmic review panel as a Class II device.