510(k) K190012 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
| Applicant | Medtrade Product, Ltd., Crewe, GB |
| Decision | Substantially Equivalent, Dec 18, 2019 |
| Received | Jan 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190012
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.