Clearance Summary
ANEUROPLASTIC, MODEL 43-1290 received FDA 510(k) clearance under submission number K071776, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-07-26.
- Submission: K071776
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5030
- Decision date: 2007-07-26
Classification & Regulation
This clearance is catalogued under FDA product code JXH and 21 CFR 882.5030, within the Neurology review panel as a Class II device.