The following data is part of a premarket notification filed by Ocular Concepts Llc. with the FDA for Natural-iris Pre-pigmented Corneal Button.
| Device ID | K001326 |
| 510k Number | K001326 |
| Device Name: | NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON |
| Classification | Button, Iris, Eye, Artificial |
| Applicant | OCULAR CONCEPTS LLC. 4035 SW MERCANTILE DR. SUITE 208 Portland, OR 97035 -2591 |
| Contact | Kevin Schou |
| Correspondent | Kevin Schou OCULAR CONCEPTS LLC. 4035 SW MERCANTILE DR. SUITE 208 Portland, OR 97035 -2591 |
| Product Code | NCK |
| CFR Regulation Number | 886.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-26 |
| Decision Date | 2000-06-13 |