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DEPARTMENT OF HEALTH HUMAN SERVICES Public Health

510(k) Submitter: John Jensen WestTec LLC 265 North Main Street Ste D-115 Kaysville Utah 84037 Phone: 435-200-4608 E-mail: jjensenwesttec us Device Trade Names: WestTec Procedure Facemask WestTec Surgical Facemask Device Common Name: Surgical Mask Classification Name: Surgical apparel Device Classification Class II per 21 CFR 878 4040

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