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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 K202491
Device Name Disposable Surgical Face Mask
Applicant
Jiangsu Newvalue Medical Products Co., Ltd.
Bldg. G35, # I Ave., China Medical City
Taizhou,  CN 225300
Applicant Contact Zhou Zhengguo
Correspondent
Shanghai Medical Business Consulting Co., Ltd.
Rm. 304, No 170 Huajiang Rd., Jiading District
Shanghai,  CN 201803
Correspondent Contact Julie Chen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/31/2020
Decision Date 01/06/2021
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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