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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 K040956
Device Name HILUX LEDMAX 3
Applicant
First Medical Infection Control Associates, Inc.
3704-C Boren Dr.
Greensboro,  NC  27407
Applicant Contact DAVID SMALL
Correspondent
First Medical Infection Control Associates, Inc.
3704-C Boren Dr.
Greensboro,  NC  27407
Correspondent Contact DAVID SMALL
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received04/13/2004
Decision Date 06/14/2004
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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