510(k) K120335 ยท IYE Accelerator, Linear, Medical
EMBRACE THERMOPLASTIC
| Applicant | Bionix Development Corp., Toledo OH, US |
| Decision | Substantially Equivalent, May 3, 2012 |
| Received | Feb 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120335
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.