The following data is part of a premarket notification filed by Lobob Laboratories, Inc. with the FDA for Optimum Wetting And Rewetting Drop.
| Device ID | K001428 |
| 510k Number | K001428 |
| Device Name: | OPTIMUM WETTING AND REWETTING DROP |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | LOBOB LABORATORIES, INC. 2000 M ST. NW # 700 Washington, DC 20036 -3307 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli LOBOB LABORATORIES, INC. 2000 M ST. NW # 700 Washington, DC 20036 -3307 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-05 |
| Decision Date | 2000-05-26 |