Clearance Summary
FLOSS CARD received FDA 510(k) clearance under submission number K882164, sponsored by Arthur Blank & Co., 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 1988-06-10.
- Submission: K882164
- Applicant / Sponsor: Arthur Blank & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1988-06-10
Classification & Regulation
This clearance is catalogued under FDA product code JES and 21 CFR 872.6390, within the Dental review panel as a Class I device.