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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 K172500
Device Name Technoweb Surgical Mask
Applicant
YTS GLOBAL INC.
7406 ALBAN STATION CT STE A 108
SPRINGFIELD,  VA  22150
Applicant Contact Eddie Nguyen
Correspondent
YTS GLOBAL INC.
7406 ALBAN STATION COURT SUITE A108
Springfield,  VA  22150
Correspondent Contact Eddie Nguyen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/18/2017
Decision Date 03/01/2018
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
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