510(k) K912107 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Oct 11, 1991 |
| Received | May 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912107
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.