MONARCH NASAL IMPLANT
Device Facts
| Record ID | K071018 |
|---|---|
| Device Name | MONARCH NASAL IMPLANT |
| Applicant | Hanson Medical, Inc. |
| Product Code | FZE · General, Plastic Surgery |
| Decision Date | May 25, 2007 |
| 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.
