510(k) K161067 · QSZ Absorbable Synthetic Wound Dressing
Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen Advanced Wound Matrix, 1x6
| Applicant | Engineered Tissue Solutions, LLC, Rolla MO, US |
| Decision | Substantially Equivalent, Sep 15, 2016 |
| Received | Apr 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161067
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.