GORE-TEX SAM FACIAL IMPLANT
Device Facts
| Record ID | K946267 |
|---|---|
| Device Name | GORE-TEX SAM FACIAL IMPLANT |
| Applicant | W. L. Gore & Associates, Inc. |
| Product Code | FWP · General, Plastic Surgery |
| Decision Date | Mar 22, 1995 |
| 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.
