The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Aquify Multipurpose Solution.
Device ID | K050250 |
510k Number | K050250 |
Device Name: | AQUIFY MULTIPURPOSE SOLUTION |
Classification | Accessories, Soft Lens Products |
Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
Contact | Steven Dowdley |
Correspondent | Steven Dowdley CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-03 |
Decision Date | 2005-08-10 |