The following data is part of a premarket notification filed by Sauflon Pharmaceuticals, Ltd. with the FDA for Sauflon Flat Lens Case/sauflon 2003 Barrel Lens Case.
| Device ID | K033656 |
| 510k Number | K033656 |
| Device Name: | SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE |
| Classification | Case, Contact Lens |
| 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 | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-21 |
| Decision Date | 2004-02-02 |
| Summary: | summary |