Clearance Summary
CEMENT FUME EVACUATOR TANK & FILTER received FDA 510(k) clearance under submission number K810542, sponsored by Walgen Medical Innoventions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1981-03-13.
- Submission: K810542
- Applicant / Sponsor: Walgen Medical Innoventions
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4220
- Decision date: 1981-03-13
Classification & Regulation
This clearance is catalogued under FDA product code JDY and 21 CFR 888.4220, within the Orthopedic review panel as a Class I device.