Clearance Summary
OOLI-U(TONGUE SCRAPER) received FDA 510(k) clearance under submission number K970042, sponsored by Telefax Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-03-14.
- Submission: K970042
- Applicant / Sponsor: Telefax Intl.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1997-03-14
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.