The following data is part of a premarket notification filed by Chen Ophthalmic Laboratories with the FDA for The Chen Medium.
| Device ID | K954548 |
| 510k Number | K954548 |
| Device Name: | THE CHEN MEDIUM |
| Classification | Media, Corneal Storage |
| Applicant | CHEN OPHTHALMIC LABORATORIES 13704 KILLARNEY COURT Phoenix, MD 21131 |
| Contact | Chung-ho Chen |
| Correspondent | Chung-ho Chen CHEN OPHTHALMIC LABORATORIES 13704 KILLARNEY COURT Phoenix, MD 21131 |
| Product Code | LYX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1996-05-20 |