510(k) K211318 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
| Applicant | Smith Nephew Medical Limited, Hull, GB |
| Decision | Substantially Equivalent, Jan 5, 2022 |
| Received | Apr 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211318
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.