510(k) K974171 ยท KZH Introducer, Syringe Needle
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
| Applicant | Teva Medical, Ltd., Kulpsville PA, US |
| Decision | Substantially Equivalent, Dec 19, 1997 |
| Received | Nov 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974171
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.