FDA 510(k) Application Details - K063465

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K063465
Device Name Device, Iontophoresis, Other Uses
Applicant IOMED, INC.
2441 SOUTH 3850 WEST, SUITE A
SALT LAKE CITY, UT 84120-9941 US
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Contact CURTIS JENSON
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 11/16/2006
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 N
Expedited Review



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