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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
Device Name PRECISE SHP DIODE LASER
Applicant
CAO GROUP, INC.
4628 WEST SKYHAWK DRIVE
WEST JORDAN,  UT  84084
Applicant Contact ROB K LARSEN
Correspondent
CAO GROUP, INC.
4628 WEST SKYHAWK DRIVE
WEST JORDAN,  UT  84084
Correspondent Contact ROB K LARSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/22/2011
Decision Date 08/30/2012
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
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