510(k) K831516 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
GORE-TEX SURGICAL MEMBRANE
| Applicant | W. L. Gore & Associates, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jan 6, 1984 |
| Received | Mar 10, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831516
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.