Clearance Summary
GUM MACHINE received FDA 510(k) clearance under submission number K831321, sponsored by The Gum Machine Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1983-07-07.
- Submission: K831321
- Applicant / Sponsor: The Gum Machine Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1983-07-07
Classification & Regulation
This clearance is catalogued under FDA product code EFS and 21 CFR 872.6510, within the Dental review panel as a Class I device.