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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 K093751
Device Name CL-DC20, CL-DC21
Applicant
Good Doctors Co., Ltd.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Applicant Contact KEVIN WALLS, RAC
Correspondent
Good Doctors Co., Ltd.
5401 S Cottonwood Ct.
Greenwood Village,  CO  80121
Correspondent Contact KEVIN WALLS, RAC
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received12/07/2009
Decision Date 02/24/2010
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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