ClearanceBrief
510(k) K964158 ยท EJT Alloy, Gold-Based Noble Metal

JEL-40 (CODE NAME RD-0430)

ApplicantJelenko Co., Armonk NY, US
DecisionSubstantially Equivalent, Dec 13, 1996
ReceivedOct 16, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K964158

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.