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FDA 510(k) Application Details - K030395
Device Classification Name
Device, Iontophoresis, Other Uses
More FDA Info for this Device
510(K) Number
K030395
Device Name
Device, Iontophoresis, Other Uses
Applicant
EMPI
1800 MASSACHUSETTS AVE NW
SUITE 200
WASHINGTON, DC 20036-1221 US
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Contact
SUSAN ONEL
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
02/05/2003
Decision Date
04/08/2003
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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