Clearance Summary
CMW CEMENT PRESSURISATION SYSTEM received FDA 510(k) clearance under submission number K897134, sponsored by Dentsply Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-03-02.
- Submission: K897134
- Applicant / Sponsor: Dentsply Intl.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4200
- Decision date: 1990-03-02
Classification & Regulation
This clearance is catalogued under FDA product code KIH and 21 CFR 888.4200, within the Orthopedic review panel as a Class I device.