ClearanceBrief
510(k) K801764 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

IONESCU-SHILEY PERICARDIAL PATCH

ApplicantShiley, Inc., Walker MI, US
DecisionSubstantially Equivalent, Aug 13, 1980
ReceivedJul 28, 1980
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K801764

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.