The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Viscous Fluid Injector System Module (cx5700).
| Device ID | K993039 |
| 510k Number | K993039 |
| Device Name: | VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Vanada Johnson |
| Correspondent | Vanada Johnson BAUSCH & LOMB, INC. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-10 |
| Decision Date | 2000-01-07 |
| Summary: | summary |