510(k) K964192 ยท EJJ Alloy, Amalgam
ARDENT NON GAMMA-2 70
| Applicant | Ardent Production Development, Tonawanda NY, US |
| Decision | Substantially Equivalent, Jan 6, 1997 |
| Received | Oct 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964192
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.