510(k) K912195 ยท EJS Alloy, Other Noble Metal
PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE
| Applicant | Jelenko Co., Armonk NY, US |
| Decision | Substantially Equivalent, Jul 30, 1991 |
| Received | May 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912195
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.