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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 K202697
Device Name United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
Applicant
United Sewing Automation, Inc.
1772 N. Andy Griffith Pkwy.
Mount Airy,  NC  27030
Applicant Contact Benjamin Webb
Correspondent
Womble Bond Dickinson, US Llp
One W. Fourth St.
Winston-Salem,  NC  27101
Correspondent Contact Heather Hatcher
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/16/2020
Decision Date 05/13/2021
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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