The following data is part of a premarket notification filed by Sauflon Pharmaceuticals, Ltd. with the FDA for Sauflon Multipurpose Solution.
| Device ID | K130734 |
| 510k Number | K130734 |
| Device Name: | SAUFLON MULTIPURPOSE SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. Twickenham, Middlesex, GB Tw1-3lp |
| Contact | Christopher Smejkal |
| Correspondent | Christopher Smejkal SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. Twickenham, Middlesex, GB Tw1-3lp |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-05-15 |
| Summary: | summary |