510(k) K130006 ยท PAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
| Applicant | Cook Biotech Incorporated, West Lafayette IN, US |
| Decision | Substantially Equivalent, Apr 5, 2013 |
| Received | Jan 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130006
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.