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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 K232359
Device Name Surgical face mask
Applicant
Kingstar Medical (Xianning) Co., Ltd.
No.79 Yong'andong Road, Xian'an District
Xianning,  CN
Applicant Contact Fan Rong
Correspondent
Shanghai Sungo Management Consulting Co. Ltd.
14th Floor, 1500# Century Avenue
Shanghai,  CN
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/07/2023
Decision Date 10/02/2023
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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