The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Aosept Plus Cleaning And Disinfecting Solution.
| Device ID | K003345 |
| 510k Number | K003345 |
| Device Name: | AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION |
| Classification | Accessories, Soft Lens Products |
| 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 | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-25 |
| Decision Date | 2001-03-26 |