The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Surgical Mask.
| Device ID | K801036 |
| 510k Number | K801036 |
| Device Name: | SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-02 |
| Decision Date | 1980-06-04 |