Clearance Summary
BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED received FDA 510(k) clearance under submission number K884515, sponsored by Gatewood and Associates, 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 1989-01-10.
- Submission: K884515
- Applicant / Sponsor: Gatewood and Associates, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1989-01-10
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.