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) Contact Lenses, Durasoft 3 Uv (phemfilcon A) Spherical (hydropi.
Device ID | K993935 |
510k Number | K993935 |
Device Name: | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI |
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 | 1999-11-19 |
Decision Date | 1999-12-21 |
Summary: | summary |