510(k) K160578 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Nustat XR
| Applicant | Beeken Biomedical, LLC, Stoughton MA, US |
| Decision | Substantially Equivalent, Jun 29, 2016 |
| Received | Mar 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160578
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.