Clearance Summary
COLLI-MATETM MODEL NO. B800 received FDA 510(k) clearance under submission number K874687, sponsored by Summit Industries, 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 1987-12-30.
- Submission: K874687
- Applicant / Sponsor: Summit Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1987-12-30
Classification & Regulation
This clearance is catalogued under FDA product code IZX and 21 CFR 892.1610, within the Radiology review panel as a Class II device.