The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Myday (stenfilcon A) Asphere, Myday (stenfilcon A) Toric, Myday (stenfilcon A) Multifocal, Myday (stenfilcon A) Multifocal Toric.
| Device ID | K191763 |
| 510k Number | K191763 |
| Device Name: | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CooperVision, Inc. 5870 Stoneridge Drive, Suite 1 Pleasanton, CA 94588 |
| Contact | Marie Dutton |
| Correspondent | Marie Dutton CooperVision, Inc. 5870 Stoneridge Drive, Suite 1 Pleasanton, CA 94588 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2020-03-23 |
| Summary: | summary |