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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
Original Applicant
LUTRONIC CORPORATION
6 neshaminy interplex,
suite 207
trevose,  PA  19053
Original Contact jhung won vojir
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/13/2011
Decision Date 06/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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