The following data is part of a premarket notification filed by Nissel Ltd. with the FDA for The Nissel Artificial Eye.
| Device ID | K923167 |
| 510k Number | K923167 |
| Device Name: | THE NISSEL ARTIFICIAL EYE |
| Classification | Eye, Artificial, Non-custom |
| Applicant | NISSEL LTD. 151 NORTH MICHIGAN AVE. SUITE 2114 Chicago, IL 60601 |
| Contact | John Szabocsik |
| Correspondent | John Szabocsik NISSEL LTD. 151 NORTH MICHIGAN AVE. SUITE 2114 Chicago, IL 60601 |
| Product Code | HQH |
| CFR Regulation Number | 886.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1992-09-02 |