Clearance Summary
TRI HAWK BUR, FG BUR received FDA 510(k) clearance under submission number K943273, sponsored by Tri Hawk Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-08-01.
- Submission: K943273
- Applicant / Sponsor: Tri Hawk Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3240
- Decision date: 1994-08-01
Classification & Regulation
This clearance is catalogued under FDA product code EJL and 21 CFR 872.3240, within the Dental review panel as a Class I device.