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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 K202628
Device Name Disposable Medical Face Mask
Applicant
Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.,
#36 Jingsan Rd., Biological Park
Xining,  CN 810000
Applicant Contact Zhaochu Chen
Correspondent
Shanghai Landlink Medical Information Technology Co., Ltd.
Rm. 703, 705, Baohua International Plz.,
West Guangzhong Rd. 555, Jingan
Shanghai,  CN 200071
Correspondent Contact Shelley li
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/11/2020
Decision Date 03/19/2021
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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