510(k) K182722 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
XLR8 Abdominal Wound Dressing Kit
| Applicant | Genadyne Biotechnologies, Hicksville NY, US |
| Decision | Substantially Equivalent, Sep 27, 2019 |
| Received | Sep 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182722
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.