The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Durasoft Freshlook Uv Colors; Durasoft 3 Freshlook Uv Lite Tint.
| Device ID | K954603 |
| 510k Number | K954603 |
| Device Name: | DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESLEY JESSEN CORP. 400 WEST SUPERIOR ST. Chicago, IL 60610 |
| Contact | Rick Main |
| Correspondent | Rick Main WESLEY JESSEN CORP. 400 WEST SUPERIOR ST. Chicago, IL 60610 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-04 |
| Decision Date | 1996-01-04 |