The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Aquify Lens Comfort Drops.
| Device ID | K013204 |
| 510k Number | K013204 |
| Device Name: | AQUIFY LENS COMFORT DROPS |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2002-04-03 |
| Summary: | summary |