The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Durasoft 2 (phemfilcon A) Optifit Toric (hydrophilic) Contact Lenses, Durasoft 2 (phemfilcon A) Sherical ( Hydrophilic)c.
| Device ID | K000439 |
| 510k Number | K000439 |
| Device Name: | DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESLEY JESSEN CORP. 333 EAST HOWARD AVE. Des Plaines, IL 60018 |
| Contact | Joseph F Foos |
| Correspondent | Joseph F Foos WESLEY JESSEN CORP. 333 EAST HOWARD AVE. Des Plaines, IL 60018 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-10 |
| Decision Date | 2000-03-20 |