Clearance Summary
PREMIUM FLEXI-TOUGH received FDA 510(k) clearance under submission number K854530, sponsored by The Hygenic 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 1986-03-04.
- Submission: K854530
- Applicant / Sponsor: The Hygenic Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6890
- Decision date: 1986-03-04
Classification & Regulation
This clearance is catalogued under FDA product code EGD and 21 CFR 872.6890, within the Dental review panel as a Class I device.