510(k) K221891 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, Dec 14, 2022 |
| Received | Jun 29, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221891
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.