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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.
#79 Yong'Andong Rd., Xian'An District
Xianning,  CN
Applicant Contact Fan Rong
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
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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