510(k) K122440 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
RESTORELLE L
| Applicant | Coloplast Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 19, 2012 |
| Received | Aug 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2013 | Coloplast Manufacturing US, LLC Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark. Terminated |
OTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.