The following data is part of a premarket notification filed by Johnson & Johnson Surgical Vision, Inc. with the FDA for Unfolder Vitan Inserter.
| Device ID | K191949 |
| 510k Number | K191949 |
| Device Name: | UNFOLDER Vitan Inserter |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | Johnson & Johnson Surgical Vision, Inc. 1700 East Saint Andrew Place Santa Ana, CA 92705 |
| Contact | Silvia Jiang-hughes |
| Correspondent | Silvia Jiang-hughes Johnson & Johnson Surgical Vision, Inc. 1700 East Saint Andrew Place Santa Ana, CA 92705 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-22 |
| Decision Date | 2019-09-13 |
| Summary: | summary |