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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 K242435
Device Name Dental Barrier and Sleeves
Applicant
Wellmed Dental Medical Supply Co., Ltd
301 Zhongxin Science and Technology Building,
No.64, Xin’an 2nd Road, Baoan District
Shenzhen,  CN
Applicant Contact Renxian Tang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Luna Hu
Regulation Number878.4370
Classification Product Code
PEM  
Subsequent Product Code
PUI  
Date Received08/16/2024
Decision Date 10/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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