Clearance Summary
CHARLES/MCINTYRE GIANT BREAK TABLE received FDA 510(k) clearance under submission number K841115, sponsored by Surgi-Quip Inc.U. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1984-05-09.
- Submission: K841115
- Applicant / Sponsor: Surgi-Quip Inc.U
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1984-05-09
Classification & Regulation
This clearance is catalogued under FDA product code FQO and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.