510(k) K121485 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
| Applicant | Hemcon Medical Technologies Europe, Ltd., Portland OR, US |
| Decision | Substantially Equivalent, Aug 21, 2012 |
| Received | May 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121485
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.