510(k) K121883 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
| Applicant | Kci USA, Inc. (Kinetic Concepts, Inc.), San Antonio TX, US |
| Decision | Substantially Equivalent, Oct 11, 2012 |
| Received | Jun 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121883
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.