510(k) K080648 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
| Applicant | Ore-Medix, LLC, Midvale UT, US |
| Decision | Substantially Equivalent, May 7, 2008 |
| Received | Mar 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080648
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.