510(k) K963619 ยท FTL Mesh, Surgical, Polymeric
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Oct 25, 1996 |
| Received | Sep 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963619
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.