MEDION 6000

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 Medion 6000.

Pre-market Notification Details

Device IDK020476
510k NumberK020476
Device Name:MEDION 6000
ClassificationDevice, Iontophoresis, Other Uses
Applicant SELECTIVE MED COMPONENTS, INC. 6 MECHANIC ST. Mount Vernon,  OH  43050
ContactRichard Fisher
CorrespondentRichard Fisher
SELECTIVE MED COMPONENTS, INC. 6 MECHANIC ST. Mount Vernon,  OH  43050
Product CodeEGJ  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-12
Decision Date2002-05-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.