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 |