The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Sterile Hand Cover.
| Device ID | K894064 |
| 510k Number | K894064 |
| Device Name: | STERILE HAND COVER |
| Classification | Accessory, Surgical Apparel |
| Applicant | SAGE PRODUCTS, INC. 680 INDUSTRIAL DR. Cary, IL 60013 |
| Contact | Paul Hanifl |
| Correspondent | Paul Hanifl SAGE PRODUCTS, INC. 680 INDUSTRIAL DR. Cary, IL 60013 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1989-08-11 |