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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 K223055
Device Name Disposable Medical Face Mask
Applicant
Xiantao Zhuobo Industrial Co., Ltd.
Bldg. 1,Huanxi Rd., Pengchang Town
Xiantao,  CN
Applicant Contact Chen Xiaodong
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/29/2022
Decision Date 12/05/2022
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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