United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask

Mask, Surgical

United Sewing Automation Inc.

The following data is part of a premarket notification filed by United Sewing Automation Inc. with the FDA for United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask.

Pre-market Notification Details

Device IDK202697
510k NumberK202697
Device Name:United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask
ClassificationMask, Surgical
Applicant United Sewing Automation Inc. 1772 N. Andy Griffith Parkway Mount Airy,  NC  27030
ContactBenjamin Webb
CorrespondentHeather Hatcher
Womble Bond Dickinson, US LLP One West Fourth Street Winston-salem,  NC  27101
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-16
Decision Date2021-05-13

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