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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 K102149
Device Name GAUNYING INFRARED LAMP
Applicant
Foshan Gaunying Electronics Co., Ltd.
Hi-Tech Industrial Development
Foshan, Guangdong,  CN 52800
Applicant Contact LADI LEE
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/30/2010
Decision Date 08/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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