Clearance Summary
NEAL WRIST CONES received FDA 510(k) clearance under submission number K925924, sponsored by Neal & Assoc., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1993-04-08.
- Submission: K925924
- Applicant / Sponsor: Neal & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6760
- Decision date: 1993-04-08
Classification & Regulation
This clearance is catalogued under FDA product code FMQ and 21 CFR 880.6760, within the General Hospital review panel as a Class I device.