The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Isolation Gown.
| Device ID | K874888 |
| 510k Number | K874888 |
| Device Name: | ISOLATION GOWN |
| Classification | Gown, Isolation, Surgical |
| 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 | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-01 |
| Decision Date | 1987-12-30 |