The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Dailies Total Dalies Total For Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric.
Device ID | K113168 |
510k Number | K113168 |
Device Name: | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
Contact | Alicia M Plesnarski |
Correspondent | Alicia M Plesnarski CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-27 |
Decision Date | 2012-03-30 |
Summary: | summary |