510(k) K163217 ยท OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
GORE BIO-A Tissue Reinforcement
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Feb 10, 2017 |
| Received | Nov 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163217
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.