510(k) K161311 ยท FRO Dressing, Wound, Drug
USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles
| Applicant | Strukmyer Medical, LLC, Mesquite TX, US |
| Decision | Substantially Equivalent, Aug 29, 2016 |
| Received | May 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161311
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.