Clearance Summary
AUTOGEL PAD received FDA 510(k) clearance under submission number K031018, sponsored by Rich-Mar Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-12-08.
- Submission: K031018
- Applicant / Sponsor: Rich-Mar Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2003-12-08
Classification & Regulation
This clearance is catalogued under FDA product code MUI and 21 CFR 892.1570, within the Radiology review panel as a Class II device.