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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 K210622
Device Name Single-Use Medical Face Mask
Applicant
Jiangxi Hongda Medical Equipment Group Co., Ltd.
39 S. Shengli Rd., Jinxian County, Nanchang City,
Jiangxi Province, China
Nanchang,  CN 331700
Applicant Contact Xiaohua Yang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/02/2021
Decision Date 10/08/2021
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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