ClearanceBrief
510(k) K233999 ยท OOD Surgical Film

GalaFLEX LITE Scaffold

ApplicantTepha, Inc., Lexington MA, US
DecisionSubstantially Equivalent, Apr 9, 2024
ReceivedDec 18, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K233999

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.