Clearance Summary
HYDROXYLINE received FDA 510(k) clearance under submission number K833640, sponsored by George Taub Products & Fusion Co., 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 1984-02-27.
- Submission: K833640
- Applicant / Sponsor: George Taub Products & Fusion Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3250
- Decision date: 1984-02-27
Classification & Regulation
This clearance is catalogued under FDA product code EJK and 21 CFR 872.3250, within the Dental review panel as a Class II device.