FDA 510(k) Application Details - K040495

Device Classification Name Device, Iontophoresis, Other Uses

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510(K) Number K040495
Device Name Device, Iontophoresis, Other Uses
Applicant NAIMCO, INC.
4120 SOUTH CREEK ROAD
CHATTANOOGA, TN 37406 US
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Contact ROBERT L MCCLURE
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Regulation Number 890.5525

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Classification Product Code EGJ
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Date Received 02/26/2004
Decision Date 04/22/2004
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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