Clearance Summary
ROYAL MARSDEN GOLD GRAIN GUN received FDA 510(k) clearance under submission number K940119, sponsored by Best Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-12-30.
- Submission: K940119
- Applicant / Sponsor: Best Industries
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1994-12-30
Classification & Regulation
This clearance is catalogued under FDA product code IWS and 21 CFR 892.6500, within the Radiology review panel as a Class I device.