510(k) K212359 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
PWD Negative Pressure Wound Therapy System
| Applicant | Applied Tissue Technologies, LLC, Hingham MA, US |
| Decision | Substantially Equivalent, Sep 21, 2022 |
| Received | Jul 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212359
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.