K993039 is an FDA 510(k) clearance for the VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700). This device is classified as a Pump, Infusion, Ophthalmic (Class II - Special Controls, product code MRH).
Submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 7, 2000, 119 days after receiving the submission on September 10, 1999.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K993039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1999 |
| Decision Date | January 07, 2000 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MRH - Pump, Infusion, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |