Clearance Summary
GK ALLOY received FDA 510(k) clearance under submission number K891390, sponsored by China Link, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-04-17.
- Submission: K891390
- Applicant / Sponsor: China Link, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3070
- Decision date: 1989-04-17
Classification & Regulation
This clearance is catalogued under FDA product code EJJ and 21 CFR 872.3070, within the Dental review panel as a Class II device.