FDA 510(k) Application Details - K062792

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K062792
Device Name Device, Iontophoresis, Other Uses
Applicant ERCHONIA MEDICAL, INC.
13 RED FOX LANE
LITTLETON, CO 80127 US
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Contact KEVIN WALLS,RAC
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 09/18/2006
Decision Date 03/01/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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