Clearance Summary
IRIDIUM SEEDS received FDA 510(k) clearance under submission number K850382, sponsored by Radiation Safety & Nuclear Products, 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 1985-08-15.
- Submission: K850382
- Applicant / Sponsor: Radiation Safety & Nuclear Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 1985-08-15
Classification & Regulation
This clearance is catalogued under FDA product code IWA and 21 CFR 892.5730, within the Radiology review panel as a Class II device.