Clearance Summary
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER received FDA 510(k) clearance under submission number K023662, sponsored by Hwadong International Company , 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 2003-05-28.
- Submission: K023662
- Applicant / Sponsor: Hwadong International Company , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 2003-05-28
Classification & Regulation
This clearance is catalogued under FDA product code MCF and 21 CFR 872.6855, within the Dental review panel as a Class I device.