510(k) K161570 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large
| Applicant | Lc Medical Concepts, Inc., Penfield NY, US |
| Decision | Substantially Equivalent, Aug 29, 2016 |
| Received | Jun 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161570
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.