510(k) K193292 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Nov 27, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193292
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.