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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 K121487
Device Name LITECURE THERAPY COMPACT
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 Received05/18/2012
Decision Date 06/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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