The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Focus Dailies Visitint (nelfilcon A) One-day Contact Lens.
| Device ID | K984273 |
| 510k Number | K984273 |
| Device Name: | FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS |
| Classification | Lens, Contact, (disposable) |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-30 |
| Decision Date | 1999-01-25 |
| Summary: | summary |