The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for S.a.m. Facial Implant W/introducer.
Device ID | K964761 |
510k Number | K964761 |
Device Name: | S.A.M. FACIAL IMPLANT W/INTRODUCER |
Classification | Mesh, Surgical, Polymeric |
Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
Contact | John W Nicholson |
Correspondent | John W Nicholson W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-27 |
Decision Date | 1997-01-27 |
Summary: | summary |