The following data is part of a premarket notification filed by Ciba-geigy Corp. with the FDA for Focus Dailies (nelfilcon A) One-day Contact Lenses.
| Device ID | K003586 |
| 510k Number | K003586 |
| Device Name: | FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES |
| Classification | Lens, Contact, (disposable) |
| Applicant | CIBA-GEIGY CORP. 11460 JOHNS CREEK PKWY. Duluth, GA 30136 -1518 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley CIBA-GEIGY CORP. 11460 JOHNS CREEK PKWY. Duluth, GA 30136 -1518 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-02-08 |