The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Disposable Shoe Cover.
| Device ID | K894383 |
| 510k Number | K894383 |
| Device Name: | DISPOSABLE SHOE COVER |
| Classification | Cover, Shoe, Operating-room |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Contact | Robert T Bayer |
| Correspondent | Robert T Bayer AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka, NC 28728 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-09-12 |