510(k) K003864 ยท KZE Injector, Fluid, Non-Electrically Powered
INJEX 50 SYSTEM
| Applicant | Equidyne Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 6, 2001 |
| Received | Dec 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003864
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.