510(k) K182653 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Voyant Maryland Fusion Device
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Nov 14, 2018 |
| Received | Sep 25, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182653
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.