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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K091664
Device Name GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
Applicant
SHENZHEN GSD TECH. CO., LTD.
SUITE 8D, NO.19, LANE 999
ZHONGSHAN NO. 2 ROAD(S)
SHANGHAI,  CN 200030
Applicant Contact Diana Hong
Correspondent
SHENZHEN GSD TECH. CO., LTD.
SUITE 8D, NO.19, LANE 999
ZHONGSHAN NO. 2 ROAD(S)
SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number878.4810
Classification Product Code
ONF  
Date Received06/09/2009
Decision Date 11/16/2009
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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