Clearance Summary
WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT received FDA 510(k) clearance under submission number K925934, sponsored by Continental X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-03-04.
- Submission: K925934
- Applicant / Sponsor: Continental X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1880
- Decision date: 1993-03-04
Classification & Regulation
This clearance is catalogued under FDA product code IXY and 21 CFR 892.1880, within the Radiology review panel as a Class I device.