The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for Ciba Vision(r) Contact Lens Case.
| Device ID | K943183 |
| 510k Number | K943183 |
| Device Name: | CIBA VISION(R) CONTACT LENS CASE |
| Classification | Case, Contact Lens |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Contact | Clay Dixon |
| Correspondent | Clay Dixon CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-01 |
| Decision Date | 1994-08-04 |