510(k) K083266 ยท FTL Mesh, Surgical, Polymeric
GORE BIO-A FISTULA PLUG
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Mar 27, 2009 |
| Received | Nov 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083266
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.