The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Mattress Cover, Anti-microbial.
| Device ID | K832483 |
| 510k Number | K832483 |
| Device Name: | MATTRESS COVER, ANTI-MICROBIAL |
| Classification | Cover, Mattress (medical Purposes) |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMW |
| CFR Regulation Number | 880.6190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-25 |
| Decision Date | 1984-02-04 |