Clearance Summary
SELVERSTONE CLAMP SALIBI CLAMP received FDA 510(k) clearance under submission number K870399, 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 1987-03-06.
- Submission: K870399
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5175
- Decision date: 1987-03-06
Classification & Regulation
This clearance is catalogued under FDA product code HCE and 21 CFR 882.5175, within the Neurology review panel as a Class II device.