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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K102134
Device Name MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM
Applicant
UNITED INTEGRATED SERVICES CO., LTD.
PAOCHIAO ROAD
8F, # 4, ALLEY 1, LN 235
HSINTIEN CITY, TAIPEI HSIEN,  TW 23144
Applicant Contact DAVID O CHANG
Correspondent
UNITED INTEGRATED SERVICES CO., LTD.
PAOCHIAO ROAD
8F, # 4, ALLEY 1, LN 235
HSINTIEN CITY, TAIPEI HSIEN,  TW 23144
Correspondent Contact DAVID O CHANG
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/29/2010
Decision Date 12/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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