The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Ophthalmic Viscoinjector Drive.
| Device ID | K923326 |
| 510k Number | K923326 |
| Device Name: | OPHTHALMIC VISCOINJECTOR DRIVE |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | SYNERGETICS, INC. 2019 MEADOWBROOK WAY Chesterfield, MO 63017 |
| Contact | Donna M Scheller |
| Correspondent | Donna M Scheller SYNERGETICS, INC. 2019 MEADOWBROOK WAY Chesterfield, MO 63017 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-07 |
| Decision Date | 1992-09-30 |