The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Sam Facial Implant.
| Device ID | K961210 |
| 510k Number | K961210 |
| Device Name: | SAM FACIAL IMPLANT |
| Classification | Implant, Malar |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | John W Nicholson |
| Correspondent | John W Nicholson W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-28 |
| Decision Date | 1996-06-19 |
| Summary: | summary |