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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 K113472
Model 002-00177
Device Name PRECISE SHP DIODE LASER
Original Applicant
CAO GROUP, INC.
4628 west skyhawk drive
west jordan,  UT  84084
Original Contact rob k larsen
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/22/2011
Decision Date 08/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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