FDA 510(k) Application Details - K061849

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K061849
Device Name Device, Iontophoresis, Other Uses
Applicant AA ADVANCED TECHNOLOGY INC.
1676 VILLAGE GREEN
CROFTON, MD 21114 US
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Contact E.J. Smith
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 06/30/2006
Decision Date 04/30/2007
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 N
Expedited Review



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