The following data is part of a premarket notification filed by Mid-america Safety Corp. with the FDA for Masc Surgical Mask.
| Device ID | K211984 |
| 510k Number | K211984 |
| Device Name: | MASC Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Mid-America Safety Corp. 800 Greenleaf Avenue Elk Grove Village, IL 60007 |
| Contact | Yunxiang (phil) Fan |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-06-25 |
| Decision Date | 2021-07-25 |