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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 K003541
Device Name DENLASER, MODEL 800
Applicant
CAO GROUP, INC.
627 WEST SANDY PKWY.
SANDY,  UT  84070
Applicant Contact TRACY S BEST
Correspondent
CAO GROUP, INC.
627 WEST SANDY PKWY.
SANDY,  UT  84070
Correspondent Contact TRACY S BEST
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/16/2000
Decision Date 01/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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