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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K100143
Device Name PILOT DIODE LASER, MODEL 002-00139
Applicant
CAO Group, Inc.
4628 W. Skyhawk Dr.
West Jordan,  UT  84084
Applicant Contact ROBERT LARSEN
Correspondent
CAO Group, Inc.
4628 W. Skyhawk Dr.
West Jordan,  UT  84084
Correspondent Contact ROBERT LARSEN
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ILY  
Date Received01/19/2010
Decision Date 08/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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