FDA 510(k) Application Details - K070400

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K070400
Device Name Lamp, Infrared, Therapeutic Heating
Applicant LITECURE, LLC
930 OLD HARMONY ROAD SUITE A
NEWARK, DE 19713 US
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Contact BRIAN PRYOR, PH.D.
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 02/12/2007
Decision Date 02/28/2007
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 Y
Expedited Review



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