FDA 510(k) Application Details - K091326

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K091326
Device Name Device, Iontophoresis, Other Uses
Applicant ACTIVATEK INC.
2734 S. 3600 WEST
UNIT F
WEST VALLEY, UT 84120 US
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Contact JAMAL YANAKI
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 05/05/2009
Decision Date 05/27/2009
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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