The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for D3 (phemfilcon A) Uv Optifit Toric (hydrophilic) Contact Lenses.
| Device ID | K965052 |
| 510k Number | K965052 |
| Device Name: | D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESLEY JESSEN CORP. 333 E. HOWARD AVE. Des Plaines, IL 60018 -5903 |
| Contact | Rick Main |
| Correspondent | Rick Main 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 | 1996-12-18 |
| Decision Date | 1997-05-14 |
| Summary: | summary |