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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 K150205
Device Name LED Curing Light
Applicant
MONITEX INDUSTRIAL CO., LTD.
6F, 70 SEC. 1 GUANG-FU ROAD, SANCHONG DIST.
new taipei city,  TW 241-58
Applicant Contact shu-lung wang
Correspondent
MONITEX INDUSTRIAL CO., LTD.
6F, 70 SEC. 1 GUANG-FU ROAD, SANCHONG DIST.
new taipei city,  TW 241-58
Correspondent Contact shu-lung wang
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/29/2015
Decision Date 08/24/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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