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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K211984
Device Name MASC Surgical Mask
Applicant
Mid-America Safety Corp.
800 Greenleaf Ave.
Elk Grove Village,  IL  60007
Applicant Contact Yunxiang (Phil) Fan
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/25/2021
Decision Date 07/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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