Clearance Summary
OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE received FDA 510(k) clearance under submission number K962941, sponsored by Deep Trading 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 1996-10-08.
- Submission: K962941
- Applicant / Sponsor: Deep Trading Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1996-10-08
Classification & Regulation
This clearance is catalogued under FDA product code LCN and 21 CFR 872.6855, within the Dental review panel as a Class I device.