ClearanceBrief
510(k) K003028 ยท NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC

ApplicantOsteogenics Biomedical, Inc., Lubbock TX, US
DecisionSubstantially Equivalent, Nov 24, 2000
ReceivedSep 28, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K003028

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.