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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 K201127
Device Name DEFEND Ear-loop Face Masks
Applicant
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. E.
Earth City,  MO  63045
Applicant Contact Jose Espino
Correspondent
Young Dental Manufacturing Co.
13705 Shoreline Ct. E.
Earth City,  MO  63045
Correspondent Contact Jose Espino
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/28/2020
Decision Date 04/14/2021
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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