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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 K202069
Device Name BASE4 Disposable Medical Mask
Applicant
Base4 Group, Inc.
4393 Sunbelt Dr.
Addison,  TX  75001
Applicant Contact Jon Filipski
Correspondent
Benjamin L. England and Associates, LLC
810 Landmark Dr. Suite 126
Glen Burnie,  MD  21061
Correspondent Contact Thomas C. Knott
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/27/2020
Decision Date 12/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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