The following data is part of a premarket notification filed by Menicon Co., Ltd. with the FDA for Menicon 3% Hydrogen Peroxide Cleaning And Disinfecting Solution.
| Device ID | K191872 |
| 510k Number | K191872 |
| Device Name: | Menicon 3% Hydrogen Peroxide Cleaning And Disinfecting Solution |
| Classification | Accessories, Soft Lens Products |
| Applicant | Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku Nagoya, JP 460-0006 |
| Contact | Tetsuji Kawai |
| Correspondent | Haosheng Li Foresight Regulatory Strategies, Inc. 3-21-19, Aoi, Naka-ku 460-0006 Nagoya, JP |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-12 |
| Decision Date | 2020-03-02 |