FDA 510(k) Application Details - K083580

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K083580
Device Name Lamp, Infrared, Therapeutic Heating
Applicant LED INTELLECTUAL PROPERTIES, LLC
1131 ANTHEM VIEW LANE
KNOXVILLE, TN 37922 US
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Contact ROBERT T WAGNER
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 12/03/2008
Decision Date 06/22/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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