The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Sus (stenfilcon A) Contact Lens.
| Device ID | K131378 |
| 510k Number | K131378 |
| Device Name: | SUS (STENFILCON A) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
| Contact | Annette Nelson |
| Correspondent | Annette Nelson COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 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 | 2013-05-14 |
| Decision Date | 2013-08-30 |
| Summary: | summary |