ClearanceBrief
510(k) K231710 ยท PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers

OW100S

ApplicantSoftwave/Trt, LLC, Woodstock GA, US
DecisionSubstantially Equivalent, Sep 1, 2023
ReceivedJun 12, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231710

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.