FDA 510(k) Application Details - K080102

Device Classification Name Lamp, Infrared, Therapeutic Heating

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510(K) Number K080102
Device Name Lamp, Infrared, Therapeutic Heating
Applicant ESCADA INTERNATIONAL, INC.
13 RED FOX LN.
LITTLETON, CO 80127 US
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Contact Kevin Walls
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Regulation Number 890.5500

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Classification Product Code ILY
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Date Received 01/14/2008
Decision Date 08/20/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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