The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Solo-care Aqua Antimicrobial Lens Case.
| Device ID | K041820 |
| 510k Number | K041820 |
| Device Name: | SOLO-CARE AQUA ANTIMICROBIAL LENS CASE |
| Classification | Case, Contact Lens |
| 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 | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-07-06 |
| Decision Date | 2005-09-09 |
| Summary: | summary |