Clearance Summary
OCU-FLEX-38 (POLYMACON) received FDA 510(k) clearance under submission number K941998, sponsored by Ocu-Ease Optical Products, 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 1994-10-13.
- Submission: K941998
- Applicant / Sponsor: Ocu-Ease Optical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 1994-10-13
Classification & Regulation
This clearance is catalogued under FDA product code LPL and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.