ClearanceBrief
510(k) K022665 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE

ApplicantHohenstein Enterprises, Inc., Los Angeles CA, US
DecisionSubstantially Equivalent, Oct 9, 2002
ReceivedAug 9, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K022665

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.