Clearance Summary
ECHO GEL (RAINFOREST) received FDA 510(k) clearance under submission number K895100, sponsored by Lead-Lok, 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 1989-11-03.
- Submission: K895100
- Applicant / Sponsor: Lead-Lok, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1989-11-03
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.