510(k) K946106 ยท FTL Mesh, Surgical, Polymeric
GORE-TEX DUALMESH PLUS BIOMATERIAL
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Apr 24, 1995 |
| Received | Dec 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946106
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.