The following data is part of a premarket notification filed by Sauflon Pharmaceuticals, Ltd. with the FDA for Sauflon 55 Uv Soft (hydrophilic) Contact Lens.
| Device ID | K013649 |
| 510k Number | K013649 |
| Device Name: | SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. Twickenham, Middlesex, GB Tw1-3lp |
| Contact | Ligia Delacruz |
| Correspondent | Ligia Delacruz SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. Twickenham, Middlesex, GB Tw1-3lp |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2001-12-26 |
| Summary: | summary |