Clearance Summary
BITE BLOCK #59430 received FDA 510(k) clearance under submission number K890567, sponsored by Medi-Source, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-02-17.
- Submission: K890567
- Applicant / Sponsor: Medi-Source, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5070
- Decision date: 1989-02-17
Classification & Regulation
This clearance is catalogued under FDA product code JXL and 21 CFR 882.5070, within the Neurology review panel as a Class II device.