510(k) K123582 ยท EKX Handpiece, Direct Drive, Ac-Powered
ENDO A CLASS
| Applicant | Saeyang Microtech Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Aug 16, 2013 |
| Received | Nov 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123582
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.