510(k) K945060 ยท FTL Mesh, Surgical, Polymeric
HERNIA MESH INTRODUCTION SYSTEM
| Applicant | Gerard Medical, Inc., Charlton MA, US |
| Decision | Substantially Equivalent, Mar 2, 1995 |
| Received | Oct 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945060
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.