Clearance Summary
A MANO TONGUE CLEANSER received FDA 510(k) clearance under submission number K932839, sponsored by A Mano Products, 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 1993-09-23.
- Submission: K932839
- Applicant / Sponsor: A Mano Products, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1993-09-23
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.