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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Barriers And Sleeves
510(k) Number K250606
Device Name Dental Barrier and Sleeves
Applicant
Yueying Medical Instruments (Langfang) Co., Ltd.
Dong Xiangzhuang Village, Hou Yi Town, Yongqing County
Langfang,  CN
Applicant Contact Xiaoliang Wang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Central Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number878.4370
Classification Product Code
PEM  
Date Received02/28/2025
Decision Date 05/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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