The following data is part of a premarket notification filed by Byron Medical with the FDA for Byron Dorsal Columella Implant.
| Device ID | K863399 |
| 510k Number | K863399 |
| Device Name: | BYRON DORSAL COLUMELLA IMPLANT |
| Classification | Prosthesis, Nose, Internal |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Byron Economidy |
| Correspondent | Byron Economidy BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-09-17 |