Clearance Summary
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION received FDA 510(k) clearance under submission number K001964, sponsored by Lobob Laboratories, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-07-18.
- Submission: K001964
- Applicant / Sponsor: Lobob Laboratories, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5918
- Decision date: 2000-07-18
Classification & Regulation
This clearance is catalogued under FDA product code MRC and 21 CFR 886.5918, within the Ophthalmic review panel as a Class II device.