510(k) K821717 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
GORE-TES EXPANDED PTFE PATCH
| Applicant | W. L. Gore & Associates, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 12, 1983 |
| Received | Jun 10, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821717
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.