510(k) K153288 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Voyant Open Fusion Device
| Applicant | Applied Medical Resources, Rancho Santa CA, US |
| Decision | Substantially Equivalent, Jun 1, 2016 |
| Received | Nov 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153288
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.