FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
Device Facts
| Record ID | K925610 |
|---|---|
| Device Name | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN |
| Applicant | Microtek Medical, Inc. |
| Product Code | FWP · General, Plastic Surgery |
| Decision Date | Nov 18, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3550 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.