FDA 510(k) Application Details - K151333

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K151333
Device Name Lamp, Infrared, Therapeutic Heating
Applicant LED INTELLECTUAL PROPERTIES, LLC
16552 VON KARMAN AVE.
IRVINE, CA 92606 US
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Contact Steve Marchese
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 05/19/2015
Decision Date 08/21/2015
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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