Sovereign America Surgical Face Mask

Mask, Surgical

HomTex, Inc.

The following data is part of a premarket notification filed by Homtex, Inc. with the FDA for Sovereign America Surgical Face Mask.

Pre-market Notification Details

Device IDK201095
510k NumberK201095
Device Name:Sovereign America Surgical Face Mask
ClassificationMask, Surgical
Applicant HomTex, Inc. 2125 2nd Avenue SW Cullman,  AL  35055
ContactJeremy Wootten
CorrespondentJeremy Wootten
HomTex, Inc. 2125 2nd Avenue SW Cullman,  AL  35055
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-24
Decision Date2021-03-19

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