510(k) K002645 ยท EJT Alloy, Gold-Based Noble Metal
JEL BIOS PURE
| Applicant | J.F. Jelenko & Co., Inc., Armonk NY, US |
| Decision | Substantially Equivalent, Oct 19, 2000 |
| Received | Aug 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002645
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.