Clearance Summary
SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR received FDA 510(k) clearance under submission number K911072, sponsored by A & F Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-05-15.
- Submission: K911072
- Applicant / Sponsor: A & F Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1991-05-15
Classification & Regulation
This clearance is catalogued under FDA product code EHZ and 21 CFR 872.6640, within the Dental review panel as a Class I device.