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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 K221273
Device Name Medical Face Mask (M001)
Applicant
Xingyu Medical Tech Co., Ltd
No. 2189 Yaoqian Road, Gaomi Economic Development Zone
Weifang,  CN
Applicant Contact Carrie Li
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/02/2022
Decision Date 06/28/2022
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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