The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Facial Implant.
| Device ID | K933367 |
| 510k Number | K933367 |
| Device Name: | GORE-TEX FACIAL IMPLANT |
| Classification | Prosthesis, Chin, Internal |
| Applicant | W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. P.O. BOX 3000 Flagstaff, AZ 86003 -3000 |
| Contact | Larry J Kovach |
| Correspondent | Larry J Kovach W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. P.O. BOX 3000 Flagstaff, AZ 86003 -3000 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-09 |
| Decision Date | 1994-07-28 |