510(k) K082601 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
UltraClot, UltraClot OTC
| Applicant | Emergency Medical Devices, LLC, Wellington FL, US |
| Decision | Substantially Equivalent, Oct 9, 2008 |
| Received | Sep 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082601
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.