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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 K210101
Device Name American-Made Surgical Mask
Applicant
Armbrust, Inc.
3813 Helios Way, Bldg. B Suite 290
Pflugerville,  TX  78660
Applicant Contact Landon Morales
Correspondent
Armbrust, Inc.
3813 Helios Way, Bldg. B Suite 290
Pflugerville,  TX  78660
Correspondent Contact Landon Morales
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/14/2021
Decision Date 01/26/2022
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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