510(k) K143726 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
XLR8 PLUS (XLR8+)
| Applicant | Genadyne Biotechnologies, Inc., Hicksville NY, US |
| Decision | Substantially Equivalent, Jun 19, 2015 |
| Received | Dec 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143726
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.