The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Focus Dailies, Focus Dailies Toric And Focus Dailies Progressives One-day Soft Contact Lenses.
| Device ID | K033701 |
| 510k Number | K033701 |
| Device Name: | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES |
| Classification | Lens, Contact, (disposable) |
| Applicant | CIBA VISION CORPORATION 11440 JOHNS CREEK PKWY. Duluth, GA 30097 -1556 |
| Contact | Alicia M Plesnarski |
| Correspondent | Alicia M Plesnarski CIBA VISION CORPORATION 11440 JOHNS CREEK PKWY. Duluth, GA 30097 -1556 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-25 |
| Decision Date | 2003-12-15 |
| Summary: | summary |