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.
Device ID | K050065 |
510k Number | K050065 |
Device Name: | FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES |
Classification | Lens, Contact, (disposable) |
Applicant | CIBA VISION CORPORATION 11440 JOHNS CREEK PARKWAY Duluth, GA 30097 |
Contact | Penny Northcutt, Rac |
Correspondent | Penny Northcutt, Rac CIBA VISION CORPORATION 11440 JOHNS CREEK PARKWAY 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 | 2005-01-12 |
Decision Date | 2005-05-27 |
Summary: | summary |