510(k) K181822 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS Touch; RENASYS Y-Connector
| Applicant | Smith & Nephew Medical Limited, Hull, GB |
| Decision | Substantially Equivalent, Mar 21, 2019 |
| Received | Jul 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181822
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.