510(k) K181507 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
PREVENA RESTOR(TM) Incision Management System
| Applicant | Kci USA, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Feb 15, 2019 |
| Received | Jun 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181507
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.