Clearance Summary
ORAL IRRIGATION TIP received FDA 510(k) clearance under submission number K844318, sponsored by Pro Pulse, 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 1984-11-23.
- Submission: K844318
- Applicant / Sponsor: Pro Pulse, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1984-11-23
Classification & Regulation
This clearance is catalogued under FDA product code EFS and 21 CFR 872.6510, within the Dental review panel as a Class I device.