Clearance Summary
AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT received FDA 510(k) clearance under submission number K903808, sponsored by Advanced Med/Surg, 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 1991-01-22.
- Submission: K903808
- Applicant / Sponsor: Advanced Med/Surg, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1730
- Decision date: 1991-01-22
Classification & Regulation
This clearance is catalogued under FDA product code IZG and 21 CFR 892.1730, within the Radiology review panel as a Class II device.