510(k) K180527 ยท EKX Handpiece, Direct Drive, Ac-Powered
IS3
| Applicant | Hiossen, Inc., Fariless Hills PA, US |
| Decision | Substantially Equivalent, May 16, 2018 |
| Received | Feb 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180527
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.