510(k) K172155 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
| Applicant | Statguard, LLC, Gladstone OR, US |
| Decision | Substantially Equivalent, Apr 12, 2018 |
| Received | Jul 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172155
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.