The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Nasal Dorsum.
| Device ID | K925743 |
| 510k Number | K925743 |
| Device Name: | NASAL DORSUM |
| Classification | Prosthesis, Nose, Internal |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-13 |
| Decision Date | 1993-08-10 |