The following data is part of a premarket notification filed by Bausch & Lomb, Inc with the FDA for Bausch + Lomb Prevue Inserter For Envista Preloaded.
| Device ID | K192005 |
| 510k Number | K192005 |
| Device Name: | Bausch + Lomb PreVue Inserter For EnVista Preloaded |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | Bausch & Lomb, Inc 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122 |
| Contact | Rekha Janarthanan |
| Correspondent | Rekha Janarthanan Bausch & Lomb, Inc 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2019-10-04 |