510(k) K150129 ยท EKX Handpiece, Direct Drive, Ac-Powered
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
| Applicant | Aseptico, Inc., Woodinville WA, US |
| Decision | Substantially Equivalent, May 28, 2015 |
| Received | Jan 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150129
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.