510(k) K192667 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
gel-e Flex+ gel OTC
| Applicant | Gel-E, Inc., College Park MD, US |
| Decision | Substantially Equivalent, Oct 25, 2019 |
| Received | Sep 25, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192667
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.