510(k) K162265 ยท IYE Accelerator, Linear, Medical
CushionCast Moldable Cushions
| Applicant | Izi Medical Products, LLC, Owings Mills MD, US |
| Decision | Substantially Equivalent, Nov 15, 2016 |
| Received | Aug 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162265
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.