ClearanceBrief
510(k) K061115 ยท FPA Set, Administration, Intravascular

SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216

ApplicantGvs Spa, Manchester MI, US
DecisionSubstantially Equivalent, Jun 30, 2006
ReceivedApr 21, 2006
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K061115

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.