510(k) K142956 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
| Applicant | Integrated Healing Technologies, Franklin TN, US |
| Decision | Substantially Equivalent, Feb 24, 2015 |
| Received | Oct 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142956
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.