510(k) K143133 · OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
| Applicant | Smith & Nephew, Inc., St Petersburg FL, US |
| Decision | Substantially Equivalent, Jul 23, 2015 |
| Received | Oct 31, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143133
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.