510(k) K130943 ยท FTL Mesh, Surgical, Polymeric
AIGIS RX R PM/ AIGIS RX R ICD
| Applicant | Tyrx, Inc., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, May 20, 2013 |
| Received | Apr 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130943
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.