The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Sam Facial Implant.
| Device ID | K946267 |
| 510k Number | K946267 |
| Device Name: | GORE-TEX SAM FACIAL IMPLANT |
| Classification | Prosthesis, Chin, Internal |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P.O. BOX 900 Flagstaff, AZ 86002 -0900 |
| Contact | Thomas O'hara |
| Correspondent | Thomas O'hara W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P.O. BOX 900 Flagstaff, AZ 86002 -0900 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-23 |
| Decision Date | 1995-03-22 |