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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 K002566
Device Name LUMALITE CURE LIGHT, MODEL 2100
Applicant
Lumalite, Inc.
2810 Via Orange Way, Suite B
Spring Valley,  CA  91978
Applicant Contact JOSEPH M FOREHAND
Correspondent
Lumalite, Inc.
2810 Via Orange Way, Suite B
Spring Valley,  CA  91978
Correspondent Contact JOSEPH M FOREHAND
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received08/17/2000
Decision Date 10/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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