The following data is part of a premarket notification filed by Interpro Intl., Inc. with the FDA for Shoe Covers.
| Device ID | K874064 |
| 510k Number | K874064 |
| Device Name: | SHOE COVERS |
| Classification | Cover, Shoe, Operating-room |
| Applicant | INTERPRO INTL., INC. 2 VIEWPOINT TERRACE Lebanon, NJ 08833 |
| Contact | Wayne R Knupp |
| Correspondent | Wayne R Knupp INTERPRO INTL., INC. 2 VIEWPOINT TERRACE Lebanon, NJ 08833 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-05 |
| Decision Date | 1987-11-04 |