K946267 is an FDA 510(k) clearance for the GORE-TEX SAM FACIAL IMPLANT. This device is classified as a Prosthesis, Chin, Internal (Class II - Special Controls, product code FWP).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on March 22, 1995, 89 days after receiving the submission on December 23, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K946267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1994 |
| Decision Date | March 22, 1995 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FWP — Prosthesis, Chin, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |