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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Mask With Antimicrobial/Antiviral Agent
510(k) Number K231741
Device Name ProGear® Surgical Mask with Oxafence®, Model AV82030
Applicant
Prestige Ameritech
7201 Iron Horse Blvd.
North Richland Hills,  TX  76180
Applicant Contact Hofheinz Danica
Correspondent
Prestige Ameritech
7201 Iron Horse Blvd.
North Richland Hills,  TX  76180
Correspondent Contact Danica Hofheinz
Regulation Number878.4040
Classification Product Code
OUK  
Subsequent Product Code
FXX  
Date Received06/14/2023
Decision Date 09/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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