510(k) K150006 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing
| Applicant | Kci USA, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Nov 6, 2015 |
| Received | Jan 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150006
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.