510(k) K143301 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
| Applicant | Integrated Healing Technologies, Franklin TN, US |
| Decision | Substantially Equivalent, Mar 3, 2015 |
| Received | Nov 17, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143301
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.