The following data is part of a premarket notification filed by Omega Silicone, Inc. with the FDA for Omega Dorsal Columella Implants.
| Device ID | K871071 |
| 510k Number | K871071 |
| Device Name: | OMEGA DORSAL COLUMELLA IMPLANTS |
| Classification | Prosthesis, Nose, Internal |
| Applicant | OMEGA SILICONE, INC. 725 YANONALI Santa Barbara, CA 93103 |
| Contact | Ole Johansson |
| Correspondent | Ole Johansson OMEGA SILICONE, INC. 725 YANONALI Santa Barbara, CA 93103 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-18 |
| Decision Date | 1987-04-13 |