Clearance Summary
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 received FDA 510(k) clearance under submission number K033395, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-02-25.
- Submission: K033395
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5900
- Decision date: 2004-02-25
Classification & Regulation
This clearance is catalogued under FDA product code GXO and 21 CFR 882.5900, within the Neurology review panel as a Class II device.