510(k) K161599 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
UNO Negative Pressure Wound Therapy System
| Applicant | Genadyne Biotechnologies, Inc., Hicksville NY, US |
| Decision | Substantially Equivalent, Apr 6, 2017 |
| Received | Jun 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161599
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.