GORE-TEX FACIAL IMPLANT
Device Facts
| Record ID | K933367 |
|---|---|
| Device Name | GORE-TEX FACIAL IMPLANT |
| Applicant | W. L. Gore & Associates, Inc. |
| Product Code | FWP · General, Plastic Surgery |
| Decision Date | Jul 28, 1994 |
| Decision | ST |
| 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.