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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 Building B, Suite 290
Pflugerville,  TX  78660
Applicant Contact Landon Morales
Correspondent
Armbrust Inc.
3813 Helios Way Building 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
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