The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Rurasoft 2 Freshlook Colors; Durasoft 2 Freshlook Litetint.
| Device ID | K962957 |
| 510k Number | K962957 |
| Device Name: | RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESLEY JESSEN CORP. 333 EAST HOWARD AVE. Des Plains, IL 60018 |
| Contact | Rick Main |
| Correspondent | Rick Main WESLEY JESSEN CORP. 333 EAST HOWARD AVE. Des Plains, 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 | 1996-07-30 |
| Decision Date | 1996-10-01 |
| Summary: | summary |