510(k) K132401 ยท EKX Handpiece, Direct Drive, Ac-Powered
MEGA ISQ
| Applicant | Osstell AB, Alexandria VA, US |
| Decision | Substantially Equivalent, Apr 9, 2014 |
| Received | Aug 1, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132401
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.