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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 K203161
Device Name Surgical Face Mask
Applicant
Wuhan Raytex Protection CO., LTD
RM1201,Mingchuang Building,Greenland,Heping Avenue,
Wuchang District
Wuhan,  CN 430060
Applicant Contact Maggie Yao
Correspondent
Wuhan Raytex Protection CO., LTD
RM1201,Mingchuang Building,Greenland,Heping Avenue,
Wuchang District
Wuhan,  CN 430060
Correspondent Contact Maggie Yao
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/23/2020
Decision Date 01/20/2022
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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