FDA 510(k) Application Details - K001410

Device Classification Name Device, Iontophoresis, Specific Uses

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510(K) Number K001410
Device Name Device, Iontophoresis, Specific Uses
Applicant IOMED, INC.
3385 WEST 1820 SOUTH
SALT LAKE CITY, UT 84104 US
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Contact W. TIM MILLER
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Regulation Number 890.5525

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Classification Product Code KTB
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Date Received 05/04/2000
Decision Date 08/01/2000
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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