Clearance Summary
MODEL 6500 EXTRACTION IRRIGATION SYS received FDA 510(k) clearance under submission number K791277, sponsored by Cavitron Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1979-08-22.
- Submission: K791277
- Applicant / Sponsor: Cavitron Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1979-08-22
Classification & Regulation
This clearance is catalogued under FDA product code HDQ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.