ClearanceBrief
510(k) K032976 ยท KZE Injector, Fluid, Non-Electrically Powered

BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001

ApplicantBiovalve Technologies, Inc., Worcester MA, US
DecisionSubstantially Equivalent, Apr 16, 2004
ReceivedSep 24, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K032976

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.