The following data is part of a premarket notification filed by Wells Lamont Corp. with the FDA for Cut-tec Or Wells Lamont Polyester/wire Cut-resistant Glove Liner Wells-tec, Scepter.
| Device ID | K944763 |
| 510k Number | K944763 |
| Device Name: | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER |
| Classification | Accessory, Surgical Apparel |
| Applicant | WELLS LAMONT CORP. 6640 WEST TOUHY AVE. Niles, IL 60714 |
| Contact | Wells Lamont |
| Correspondent | Wells Lamont WELLS LAMONT CORP. 6640 WEST TOUHY AVE. Niles, IL 60714 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1995-04-10 |