510(k) K001196 ยท EJT Alloy, Gold-Based Noble Metal
JEL BIOS 90 (CODE NAME RD-2401)
| Applicant | J.F. Jelenko & Co., Inc., Armonk NY, US |
| Decision | Substantially Equivalent, May 11, 2000 |
| Received | Apr 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001196
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.