The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Draw Sheet, Anti-microbial.
| Device ID | K832487 |
| 510k Number | K832487 |
| Device Name: | DRAW SHEET, ANTI-MICROBIAL |
| Classification | Bedding, Disposable, Medical |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-25 |
| Decision Date | 1984-02-13 |