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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 K163447
Device Name Premium Plus Disposable Barrier Sleeve
Applicant
Premium Plus International Limited
Flat 1001 Yuen Long Trading Centre, 33 Wang Yip St. W.
Yuen Long N.T.
Hong Kong,  CN
Applicant Contact JESSICA MAO
Correspondent
Premium Plus International Limited
Flat 1001 Yuen Long Trading Centre, 33 Wang Yip St. W.
Yuen Long N.T.
Hong Kong,  CN
Correspondent Contact JESSICA MAO
Regulation Number878.4370
Classification Product Code
PEM  
Date Received12/08/2016
Decision Date 06/20/2017
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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