510(k) K190697 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
| Applicant | Kci USA, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Mar 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190697
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.