ClearanceBrief
510(k) K081768 ยท NAJ Agents, Embolic, For Treatment Of Uterine Fibroids

COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES

ApplicantCook Incorporated, Bloomington IN, US
DecisionSubstantially Equivalent, Dec 23, 2008
ReceivedJun 20, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K081768

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.