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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 K211066
Device Name Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
Applicant
Homtex, Inc.
2125 2nd Ave. SW
Cullman,  AL  35055
Applicant Contact Jeremy Wootten
Correspondent
Homtex, Inc.
2125 2nd Ave. SW
Cullman,  AL  35055
Correspondent Contact Jeremy Wootten
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/12/2021
Decision Date 08/19/2021
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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