Clearance Summary
HUDSON CRANINAL BURRS received FDA 510(k) clearance under submission number K875224, sponsored by Tri-Med, 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 1988-01-28.
- Submission: K875224
- Applicant / Sponsor: Tri-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4310
- Decision date: 1988-01-28
Classification & Regulation
This clearance is catalogued under FDA product code HBE and 21 CFR 882.4310, within the Neurology review panel as a Class II device.