510(k) K172486 ยท FRO Dressing, Wound, Drug
Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and US
| Applicant | Anexa Biomedical, Inc., Zephyrhills FL, US |
| Decision | Substantially Equivalent, Sep 21, 2017 |
| Received | Aug 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172486
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.