510(k) K161897 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
| Applicant | Kci USA, Inc. (Kinetic Concepts, Inc.), San Antonio TX, US |
| Decision | Substantially Equivalent, Oct 4, 2016 |
| Received | Jul 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161897
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.