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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 K103511
Device Name LITECURE THERAPY SYSTEM
Applicant
Litecure, LLC
250 Corporate Blvd.
Suite B
Newark,  DE  19702
Applicant Contact LIANG LU
Correspondent
Litecure, LLC
250 Corporate Blvd.
Suite B
Newark,  DE  19702
Correspondent Contact LIANG LU
Regulation Number890.5500
Classification Product Code
ILY  
Date Received11/30/2010
Decision Date 01/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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