510(k) K110816 ยท FTL Mesh, Surgical, Polymeric
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
| Applicant | Sofradim Production, Bedford MA, US |
| Decision | Substantially Equivalent, Apr 19, 2011 |
| Received | Mar 24, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110816
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.