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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 K141085
Device Name WestTec Procedure Facemask;WestTec Surgical Facemask
Applicant
Westtec, LLC
265 N. Main St. Suite D-115
Kaysville,  UT  84037
Applicant Contact JOHN JENSEN
Correspondent
Westtec, LLC
265 N. Main St. Suite D-115
Kaysville,  UT  84037
Correspondent Contact JOHN JENSEN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/28/2014
Decision Date 03/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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