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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 K102669
Device Name DIODE LASER THERAPY SYSTEM
Applicant
China Daheng Group, Inc.
P.O. Box 237-023
Shanghai, China,  CN 100085
Applicant Contact Diana Hong
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/16/2010
Decision Date 11/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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