510(k) K121360 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
BIODESIGN ENT REPAIR GRAFT
| Applicant | Cook Biotech Incorprated, West Lafayette IN, US |
| Decision | Substantially Equivalent, Feb 27, 2013 |
| Received | May 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121360
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.