FDA 510(k) Applications for Medical Device Product Code "GXO"
(Strip, Craniosynostosis, Preformed)

FDA 510(k) Number Applicant Device Name Decision Date
K033395 Codman & Shurtleff, Inc. CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 02/25/2004
K961802 W.L. GORE & ASSOCIATES,INC PRECLUDE SYNBLOC MEMBRANE 07/31/1996


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