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FDA 510(k) Application Details - K031115
Device Classification Name
Device, Iontophoresis, Specific Uses
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510(K) Number
K031115
Device Name
Device, Iontophoresis, Specific Uses
Applicant
IOMED, INC.
2441 SOUTH 3850 WEST, SUITE A
SALT LAKE CITY, UT 84120-9941 US
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CURTIS JENSEN
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Regulation Number
890.5525
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Classification Product Code
KTB
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More FDA Info for this Product Code
Date Received
04/08/2003
Decision Date
07/10/2003
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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