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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 K061341
Device Name PALMLIGHT 10, MODEL 001-00030
Applicant
CAO Group, Inc.
8683 S. 700 W.
Sandy,  UT  84070
Applicant Contact ROBERT K LARSEN
Correspondent
CAO Group, Inc.
8683 S. 700 W.
Sandy,  UT  84070
Correspondent Contact ROBERT K LARSEN
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received05/15/2006
Decision Date 06/12/2006
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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