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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 K152561
Device Name Communicator Surgical Facemask with Clear Window
Prestige Ameritech, Ltd
7201 Iron Horse Blvd.
North Richland Hills,  TX  76180
Applicant Contact Rex Reese
Prestige Ameritech, Ltd.
7201 Iron Horse Blvd.
North Richland Hills,  TX  76180
Correspondent Contact Rex Reese
Regulation Number878.4040
Classification Product Code
Date Received09/09/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No