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FDA 510(k) Application Details - K063465
Device Classification Name
Device, Iontophoresis, Other Uses
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5525
More FDA Info for this Regulation Number
Classification Product Code
EGJ
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More FDA Info for this Product Code
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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