Clearance Summary
ORAL PHARYNGEAL CLEANSING DEVICE received FDA 510(k) clearance under submission number K905011, sponsored by Concord/Portex. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-01-31.
- Submission: K905011
- Applicant / Sponsor: Concord/Portex
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1991-01-31
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.