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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 K113668
Device Name HEALITE II SYSTEM
Applicant
Lutronic Corporation
6 Neshaminy Interplex,
Suite 207
Trevose,  PA  19053
Applicant Contact JHUNG WON VOJIR
Correspondent
Lutronic Corporation
6 Neshaminy Interplex,
Suite 207
Trevose,  PA  19053
Correspondent Contact JHUNG WON VOJIR
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/13/2011
Decision Date 06/19/2012
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
Predetermined Change
Control Plan Authorized		 No
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