510(k) K142646 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
| Applicant | Genadyne Biotechnologies, Inc., Hicksville NY, US |
| Decision | Substantially Equivalent, Apr 30, 2015 |
| Received | Sep 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142646
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.