Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3

Mask, Surgical

Homtex, Inc.

The following data is part of a premarket notification filed by Homtex, Inc. with the FDA for Sovereign America Surgical Mask, Model Number: 2000sm2, Sovereign America Surgical Mask, Model Number: 2000sm3.

Pre-market Notification Details

Device IDK211066
510k NumberK211066
Device Name:Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
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 Received2021-04-12
Decision Date2021-08-19

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