Clearance Summary
VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER received FDA 510(k) clearance under submission number K864621, sponsored by Seldoren , 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 1987-02-13.
- Submission: K864621
- Applicant / Sponsor: Seldoren , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1987-02-13
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.