The following data is part of a premarket notification filed by Unilens Corp., Usa with the FDA for C-vue 55 Toric (methafilcon A) Multifocal Contact Lens.
| Device ID | K041608 |
| 510k Number | K041608 |
| Device Name: | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | UNILENS CORP., USA 10431 72ND ST. NORTH Largo, FL 33777 |
| Contact | Josepha Bruno |
| Correspondent | Josepha Bruno UNILENS CORP., USA 10431 72ND ST. NORTH Largo, FL 33777 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-15 |
| Decision Date | 2004-07-07 |
| Summary: | summary |