Clearance Summary
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) received FDA 510(k) clearance under submission number K993039, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2000-01-07.
- Submission: K993039
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2000-01-07
Classification & Regulation
This clearance is catalogued under FDA product code MRH and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.