510(k) K210107 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
| Applicant | Genadyne Biotechnologies, Inc., Hicksville NY, US |
| Decision | Substantially Equivalent, Jun 1, 2022 |
| Received | Jan 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210107
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.