OMEGA DORSAL COLUMELLA IMPLANTS
Device Facts
| Record ID | K871071 |
|---|---|
| Device Name | OMEGA DORSAL COLUMELLA IMPLANTS |
| Applicant | Omega Silicone, Inc. |
| Product Code | FZE · General, Plastic Surgery |
| Decision Date | Apr 13, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3680 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.
