510(k) K133011 ยท OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia
DIAPHRAGMATIC HERNIA GRAFT
| Applicant | Cook Biotech, Inc., West Lafayette IN, US |
| Decision | Substantially Equivalent, Jun 20, 2014 |
| Received | Sep 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133011
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Cook Biotech, Inc. Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and Open, Classified |
OWV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.