510(k) K161658 ยท FRO Dressing, Wound, Drug
Anexa Wound Flush, Sterile Water & Sterile Normal Saline
| Applicant | Anexa Biomedical, Inc., Zephyrhills FL, US |
| Decision | Substantially Equivalent, Sep 14, 2016 |
| Received | Jun 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161658
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.