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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 K212863
Device Name Surgical Face Mask
Applicant
Taiwan Comfort Champ Manufacturing Co., Ltd.
# 55, Aly. 51, Ln. 50, Daren Rd.,
Taoyuan Dist.,
Taoyuan City,  TW 33068
Applicant Contact Jen Ke-Min
Correspondent
Chinese-European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact Jen Ke-Min
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/08/2021
Decision Date 02/19/2022
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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