OMEGA BIVALVE NASAL SPLINTS
Device Facts
| Record ID | K871073 |
|---|---|
| Device Name | OMEGA BIVALVE NASAL SPLINTS |
| Applicant | Omega Silicone, Inc. |
| Product Code | FYI · General, Plastic Surgery |
| Decision Date | May 11, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3250 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.
