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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 K210845
Device Name Disposable Surgical Mask (Model: YYKZ-01)
Applicant
Jiaxing Amazing Travel-Ware Co., Ltd.
# 2196 Honggao Rd.,
Xiuzhou Industrial Park
Jiaxing,  CN 314015
Applicant Contact Jiang Tao
Correspondent
Jiaxing Amazing Travel-Ware Co., Ltd.
# 2196 Honggao Rd.,
Xiuzhou Industrial Park
Jiaxing,  CN 314015
Correspondent Contact Jiang Tao
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/22/2021
Decision Date 10/12/2021
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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