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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 K202627
Device Name Medical Face Masks
Applicant
Guilin Hbm Sanitary Protections, Inc.
#1-2, Shuijing E. Rd.
Economic And Technological Development Area
Guilin,  CN 541805
Applicant Contact Liu Xin
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 02/03/2021
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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