IONTOPHORESIS DEVICE

Device, Iontophoresis, Other Uses

EMPI

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

Pre-market Notification Details

Device IDK903093
510k NumberK903093
Device Name:IONTOPHORESIS DEVICE
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 Received1990-07-13
Decision Date1990-10-11

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