510(k) K970339 ยท EKX Handpiece, Direct Drive, Ac-Powered
TRI AUTO ZX
| Applicant | J. Morita USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 4, 1997 |
| Received | Jan 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970339
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.