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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 K203174
Device Name Disposable Medical Mask
Applicant
Dong Guan Kinyet Metal Products Co., Ltd
NO.38, Weijian Road, Chashan Town, Dongguan City,
Guangdong Province, China
DongGuan city,  CN 523380
Applicant Contact Emily Zhang
Correspondent
IMD Medical & Drug technology service institutions
Tianbao office room 225,Sha Tai Road No.209
ShenZhen city,  CN 518117
Correspondent Contact Salon Chen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/26/2020
Decision Date 08/02/2021
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
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