510(k) K160872 ยท FRO Dressing, Wound, Drug
PolyPlex Wound Dressing
| Applicant | Global Health Solutions, LLC, Rome GA, US |
| Decision | Substantially Equivalent, Nov 23, 2016 |
| Received | Mar 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160872
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.