SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7

Device, Iontophoresis, Other Uses

SELECTIVE MED COMPONENTS, INC.

The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, And I7.

Pre-market Notification Details

Device IDK031053
510k NumberK031053
Device Name:SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
ClassificationDevice, Iontophoresis, Other Uses
Applicant SELECTIVE MED COMPONENTS, INC. 201 WEST HIGH ST. Mount Vernon,  OH  43050
ContactRichard J Fisher
CorrespondentRichard J Fisher
SELECTIVE MED COMPONENTS, INC. 201 WEST HIGH ST. Mount Vernon,  OH  43050
Product CodeEGJ  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2003-04-02
Decision Date2003-05-20
Summary:summary

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