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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 K220662
Device Name Disposable Barrier Sleeves
Applicant
Premium Plus (Dongguan) Limited
#1 Industrial Area, Tutang, Changping
Dongguan,  CN 523581
Applicant Contact Jessica Mao
Correspondent
Premium Plus (Dongguan) Limited
#1 Industrial Area, Tutang, Changping
Dongguan,  CN 523581
Correspondent Contact Jessica Mao
Regulation Number878.4370
Classification Product Code
PEM  
Date Received03/07/2022
Decision Date 05/11/2022
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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