NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE

Device, Iontophoresis, Other Uses

NORTH COAST MEDICAL, INC.

The following data is part of a premarket notification filed by North Coast Medical, Inc. with the FDA for North Coast Buffered Iontophoresis Electrode.

Pre-market Notification Details

Device IDK052019
510k NumberK052019
Device Name:NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
ClassificationDevice, Iontophoresis, Other Uses
Applicant NORTH COAST MEDICAL, INC. 18305 SUTTER BLVD. Morgan Hill,  CA  95037 -2845
ContactTarhan Kayihan
CorrespondentTarhan Kayihan
NORTH COAST MEDICAL, INC. 18305 SUTTER BLVD. Morgan Hill,  CA  95037 -2845
Product CodeEGJ  
CFR Regulation Number890.5525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2005-07-26
Decision Date2005-11-04
Summary:summary

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