The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Prosoft (phemfilcon) Soft (hydrophilic) Contact Lens.
| Device ID | K994335 |
| 510k Number | K994335 |
| Device Name: | PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS |
| 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 | 1999-12-23 |
| Decision Date | 2000-03-20 |
| Summary: | summary |