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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 K202061
Device Name Medical Face mask
Applicant
Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
#1 Jianerkang Rd., Zhixi Industry Concentration Area,
Zhixi Town, Jintan
Changzhou,  CN 213251
Applicant Contact Hongfang Tang
Correspondent
Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
#1 Jianerkang Rd., Zhixi Industry Concentration Area,
Zhixi Town, Jintan
Changzhou,  CN 213251
Correspondent Contact Hongfang Tang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/27/2020
Decision Date 12/23/2020
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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