510(k) K182323 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
PICO 7Y Single Use Negative Pressure Wound Therapy System
| Applicant | Smith & Nephew Medical Limited, Hull, GB |
| Decision | Substantially Equivalent, Jan 18, 2019 |
| Received | Aug 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182323
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.