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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 K201549
Device Name Motex Anti-Fog Surgical Face Mask
Applicant
Modern Healthcare Corp.
# 751, Sec. 2, Chung-Chou Rd.,
Tien-Chung Town, Chang-Hwa County,  TW 52045
Applicant Contact Ke-Min Jen
Correspondent
Chinese European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/09/2020
Decision Date 08/26/2020
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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