510(k) K173527 ยท PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Digitex Delivery Device
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 12, 2018 |
| Received | Nov 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173527
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.