510(k) K153199 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack
| Applicant | Kci USA, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Feb 29, 2016 |
| Received | Nov 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153199
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.