510(k) K053066 ยท FTL Mesh, Surgical, Polymeric
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
| Applicant | Genzyme Corporation, Cambridge MA, US |
| Decision | Substantially Equivalent, Dec 19, 2005 |
| Received | Nov 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053066
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.