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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K021083
Device Name VERACAM
Applicant
Lumalite, Inc.
11661 San Vicente Blvd.
Los Angeles,  CA  90049
Applicant Contact W. EDWARD JOHANSEN
Correspondent
Lumalite, Inc.
11661 San Vicente Blvd.
Los Angeles,  CA  90049
Correspondent Contact W. EDWARD JOHANSEN
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/03/2002
Decision Date 08/30/2002
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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