ClearanceBrief
510(k) K894826 ยท DTZ Oxygenator, Cardiopulmonary Bypass

UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF

ApplicantBentley Laboratories, Inc., Irvine CA, US
DecisionSubstantially Equivalent, Feb 28, 1990
ReceivedJul 31, 1989
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K894826

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.