Clearance Summary
TONGUE CLEAN received FDA 510(k) clearance under submission number K952446, sponsored by 1-800-Tongues, 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 1995-06-22.
- Submission: K952446
- Applicant / Sponsor: 1-800-Tongues, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1995-06-22
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.