Clearance Summary
BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO received FDA 510(k) clearance under submission number K790877, sponsored by Stackhouse Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1979-05-23.
- Submission: K790877
- Applicant / Sponsor: Stackhouse Assoc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4220
- Decision date: 1979-05-23
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.