The following data is part of a premarket notification filed by Sudreca Surgical Dressings, Inc. with the FDA for Surgical Apparel Shoe Covers.
| Device ID | K831952 |
| 510k Number | K831952 |
| Device Name: | SURGICAL APPAREL SHOE COVERS |
| Classification | Shoe And Shoe Cover, Conductive |
| Applicant | SUDRECA SURGICAL DRESSINGS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-15 |
| Decision Date | 1983-07-12 |