510(k) K140533 ยท OOD Surgical Film
GALAFLEX MESH
| Applicant | Tepha, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, May 21, 2014 |
| Received | Mar 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140533
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.