510(k) K222919 · OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
GORE® ENFORM Biomaterial
| Applicant | W. L. Gore and Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Dec 19, 2022 |
| Received | Sep 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222919
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.