510(k) K970068 ยท EJT Alloy, Gold-Based Noble Metal
JELENKO NO.1 (CODE NAME RD-0601)
| Applicant | J.F. Jelenko & Co., Inc., Armonk NY, US |
| Decision | Substantially Equivalent, Mar 24, 1997 |
| Received | Jan 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970068
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.