ClearanceBrief
510(k) K130006 ยท PAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS

ApplicantCook Biotech Incorporated, West Lafayette IN, US
DecisionSubstantially Equivalent, Apr 5, 2013
ReceivedJan 2, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K130006

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.