510(k) K112322 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
RESTORELLE POLYPROPYLENE Y MESH
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, May 17, 2012 |
| Received | Aug 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112322
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.