The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Gentle Touch Uv (netrafilcon A) Soft Contact Lenses.
| Device ID | K991000 |
| 510k Number | K991000 |
| Device Name: | GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESLEY JESSEN CORP. 333 E. HOWARD AVE. Des Plaines, IL 60018 -5903 |
| Contact | Joseph Foos |
| Correspondent | Joseph Foos 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 | 1999-03-24 |
| Decision Date | 1999-06-28 |
| Summary: | summary |