The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Durasoft 3 Uv (phemfilcon A) Optifit Toric (hydrophilic Contac Lenses, Durasoft 3 Uv (phemfilcon A) Spherical (hydrophis.
| Device ID | K982344 |
| 510k Number | K982344 |
| Device Name: | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESLEY JESSEN CORP. 333 E. HOWARD AVE. Des Plaines, IL 60018 -5903 |
| Contact | Joseph Foos |
| Correspondent | Joseph Foos WESLEY JESSEN CORP. 333 E. HOWARD AVE. Des Plaines, IL 60018 -5903 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-06 |
| Decision Date | 1998-12-22 |
| Summary: | summary |