The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Focus Dailies Progressives.
Device ID | K003826 |
510k Number | K003826 |
Device Name: | FOCUS DAILIES PROGRESSIVES |
Classification | Lens, Contact, (disposable) |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
Contact | Alicia M Plesnarski |
Correspondent | Alicia M Plesnarski 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 | 2000-12-11 |
Decision Date | 2001-03-08 |