TBD IONTOPHORESIS ELECTRODE

Device, Iontophoresis, Other Uses

EMPI

The following data is part of a premarket notification filed by Empi with the FDA for Tbd Iontophoresis Electrode.

Pre-market Notification Details

Device IDK896703
510k NumberK896703
Device Name:TBD IONTOPHORESIS ELECTRODE
ClassificationDevice, Iontophoresis, Other Uses
Applicant EMPI 1275 GREY FOX RD. St Paul,  MN  55112
ContactStacy Mattson
CorrespondentStacy Mattson
EMPI 1275 GREY FOX RD. St Paul,  MN  55112
Product CodeEGJ  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-28
Decision Date1990-02-26

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