510(k) K973594 ยท LYC Bone Grafting Material, Synthetic
GORE RESOLUT XT REGENERATIVE MATERIAL
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Dec 17, 1997 |
| Received | Sep 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973594
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.