510(k) K180893 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
IHM Technology Bandage
| Applicant | Protege Biomedical, Eden Prairie MN, US |
| Decision | Substantially Equivalent, Sep 19, 2018 |
| Received | Apr 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180893
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.