Clearance Summary
MTD HEDREST received FDA 510(k) clearance under submission number K884847, sponsored by Composites Horizons, 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 1989-01-09.
- Submission: K884847
- Applicant / Sponsor: Composites Horizons, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1920
- Decision date: 1989-01-09
Classification & Regulation
This clearance is catalogued under FDA product code IWY and 21 CFR 892.1920, within the Radiology review panel as a Class I device.