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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 K152192
Device Name LED Curing Light
Applicant
Monitex Industrial Co., Ltd.
6f, 70 Sec. 1 Guang-Fu Rd.
San-Chong Dist.
New Taipei City,  TW 241-58
Applicant Contact Shu-Lung Wang
Correspondent
Monitex Industrial Co., Ltd.
6f, 70 Sec. 1 Guang-Fu Rd.
San-Chong Dist.
New Taipei City,  TW 241-58
Correspondent Contact Shu-Lung Wang
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received08/05/2015
Decision Date 04/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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