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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 K895085
Device Name WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT
Applicant
Lustgarten Multi-Tech International, Inc.
1661 Worcester Rd., Suite 201
Framingham,  MA  01701
Applicant Contact STEWART LUSTGARTEN
Correspondent
Lustgarten Multi-Tech International, Inc.
1661 Worcester Rd., Suite 201
Framingham,  MA  01701
Correspondent Contact STEWART LUSTGARTEN
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received08/14/1989
Decision Date 04/02/1990
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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