Clearance Summary
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 received FDA 510(k) clearance under submission number K071791, 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 2007-07-30.
- Submission: K071791
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5300
- Decision date: 2007-07-30
Classification & Regulation
This clearance is catalogued under FDA product code GXP and 21 CFR 882.5300, within the Neurology review panel as a Class II device.