510(k) K964761 ยท FTL Mesh, Surgical, Polymeric
S.A.M. FACIAL IMPLANT W/INTRODUCER
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Jan 27, 1997 |
| Received | Nov 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964761
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.