Clearance Summary
THE FUGO BLADE FOR DENTISTRY received FDA 510(k) clearance under submission number K063468, sponsored by Medisurg , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-04-18.
- Submission: K063468
- Applicant / Sponsor: Medisurg , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4920
- Decision date: 2007-04-18
Classification & Regulation
This clearance is catalogued under FDA product code EKZ and 21 CFR 872.4920, within the Dental review panel as a Class II device.