Clearance Summary
CODMAN PEDIATRIC HORSESHOE HEADREST received FDA 510(k) clearance under submission number K911917, 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 1991-07-17.
- Submission: K911917
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4440
- Decision date: 1991-07-17
Classification & Regulation
This clearance is catalogued under FDA product code HBM and 21 CFR 882.4440, within the Neurology review panel as a Class I device.