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FDA 510(k) Application Details - K983484
Device Classification Name
Device, Iontophoresis, Other Uses
More FDA Info for this Device
510(K) Number
K983484
Device Name
Device, Iontophoresis, Other Uses
Applicant
EMPI
599 CARDIGAN RD.
ST. PAUL, MN 55126 US
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Contact
CAROLYN M STEELE HUSTEN
Other 510(k) Applications for this Contact
Regulation Number
890.5525
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Classification Product Code
EGJ
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More FDA Info for this Product Code
Date Received
10/05/1998
Decision Date
12/28/1998
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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