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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 K210102
Device Name Topwide Surgical Face Mask
Applicant
Topwide (Hubei) Medical Products Manufacturer
19 Xianhong Rd., Xin Li Ren Kou
Xiantao,  CN 433012
Applicant Contact Shoucheng Zhang
Correspondent
Lee and Xiao
2600 Mission St., Suite 206
San Marino,  CA  91108
Correspondent Contact Jimmy Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/14/2021
Decision Date 12/17/2021
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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