SILICONE ELASTOMER MALAR IMPLANT
Device Facts
| Record ID | K952707 |
|---|---|
| Device Name | SILICONE ELASTOMER MALAR IMPLANT |
| Applicant | Spirit Ridge Technologies |
| Product Code | FZE · General, Plastic Surgery |
| Decision Date | Aug 28, 1995 |
| 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.
