510(k) K161935 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Avance Foam Dressing Kit - XL
| Applicant | Molnlycke Health Care Us, LLC, Norcross GA, US |
| Decision | Substantially Equivalent, Nov 4, 2016 |
| Received | Jul 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161935
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.