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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K153514
Device Name Premium Plus C01/C02 LED Curing Light
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 Number872.6070
Classification Product Code
EBZ  
Date Received12/07/2015
Decision Date 08/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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