510(k) K180829 ยท FTL Mesh, Surgical, Polymeric
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jun 28, 2018 |
| Received | Mar 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180829
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.