Clearance Summary
AUTOMATIC TRAY (ACT I & ACT II received FDA 510(k) clearance under submission number K820117, sponsored by Burbury & Cutter Ind., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1982-02-18.
- Submission: K820117
- Applicant / Sponsor: Burbury & Cutter Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1860
- Decision date: 1982-02-18
Classification & Regulation
This clearance is catalogued under FDA product code KPX and 21 CFR 892.1860, within the Radiology review panel as a Class II device.