Clearance Summary
WIRE CUTTING PLIERS OR LINEMAN'S PLIERS received FDA 510(k) clearance under submission number K854390, sponsored by Med-Tool, Inc.. 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 1985-11-19.
- Submission: K854390
- Applicant / Sponsor: Med-Tool, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1985-11-19
Classification & Regulation
This clearance is catalogued under FDA product code HTC and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.