Clearance Summary
CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER received FDA 510(k) clearance under submission number K944763, sponsored by Wells Lamont Corp.. 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 1995-04-10.
- Submission: K944763
- Applicant / Sponsor: Wells Lamont Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1995-04-10
Classification & Regulation
This clearance is catalogued under FDA product code LYU and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.