The following data is part of a premarket notification filed by Cui Corp. with the FDA for Cui Dorsal Columella Prosthesis.
| Device ID | K904350 |
| 510k Number | K904350 |
| Device Name: | CUI DORSAL COLUMELLA PROSTHESIS |
| Classification | Prosthesis, Nose, Internal |
| Applicant | CUI CORP. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Contact | Morris Sherwood |
| Correspondent | Morris Sherwood CUI CORP. P.O. BOX 40288 Santa Barbara, CA 93140 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1990-11-26 |