510(k) K153582 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Prometheus ChitoGauze XR PRO
| Applicant | Hem Con Medical Technologies, Inc., Portland OR, US |
| Decision | Substantially Equivalent, May 25, 2016 |
| Received | Dec 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153582
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.