The following data is part of a premarket notification filed by Visionary Technologies Of Miami, Inc. with the FDA for Keratoplasty Suturing Lens.
| Device ID | K940106 |
| 510k Number | K940106 |
| Device Name: | KERATOPLASTY SUTURING LENS |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | VISIONARY TECHNOLOGIES OF MIAMI, INC. 8306 MILLS DRIVE, SUITE 147 Miami, FL 33183 |
| Contact | Thomas Mestrits |
| Correspondent | Thomas Mestrits VISIONARY TECHNOLOGIES OF MIAMI, INC. 8306 MILLS DRIVE, SUITE 147 Miami, FL 33183 |
| Product Code | HPX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-10 |
| Decision Date | 1994-05-25 |