The following data is part of a premarket notification filed by Sauflon Pharmaceuticals, Ltd. with the FDA for Sauflon Aerotab Disinfecting System For The Disinfection Of Soft (hydrophilic) Contact Lenses.
| Device ID | K991125 |
| 510k Number | K991125 |
| Device Name: | SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES |
| Classification | Accessories, Soft Lens Products |
| 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 | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-02 |
| Decision Date | 1999-09-14 |
| Summary: | summary |