The following data is part of a premarket notification filed by Sauflon Pharmaceuticals, Ltd. with the FDA for Delta Plus Multiaction Solution For Rigid Gas Permeable Contact Lenses.
| Device ID | K011456 |
| 510k Number | K011456 |
| Device Name: | DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | SAUFLON PHARMACEUTICALS, LTD. 203 N. WABASH AVE. SUITE 1200 Chicago, IL 60601 |
| Contact | John M Szabocsik |
| Correspondent | John M Szabocsik SAUFLON PHARMACEUTICALS, LTD. 203 N. WABASH AVE. SUITE 1200 Chicago, IL 60601 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-11 |
| Decision Date | 2001-07-17 |