510(k) K153270 ยท IYE Accelerator, Linear, Medical
TruGuard Custom Tongue and Jaw Positioner
| Applicant | Bionix Development Corp., Toledo OH, US |
| Decision | Substantially Equivalent, Mar 8, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153270
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.