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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 K071908
Device Name DOCTOR'S LIGHT LED DENTAL CURING LIGHT
Applicant
Good Doctors Co., Ltd.
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Applicant Contact IAN P GORDON
Correspondent
Good Doctors Co., Ltd.
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Correspondent Contact IAN P GORDON
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received07/10/2007
Decision Date 08/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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