2.5 FRENCH LITHOTRIPTOR ELECTRODE

Lithotriptor, Electro-hydraulic

NORTHGATE RESEARCH, INC.

The following data is part of a premarket notification filed by Northgate Research, Inc. with the FDA for 2.5 French Lithotriptor Electrode.

Pre-market Notification Details

Device IDK894704
510k NumberK894704
Device Name:2.5 FRENCH LITHOTRIPTOR ELECTRODE
ClassificationLithotriptor, Electro-hydraulic
Applicant NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights,  IL  60004
ContactD Emrich
CorrespondentD Emrich
NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights,  IL  60004
Product CodeFFK  
CFR Regulation Number876.4480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-25
Decision Date1989-10-18

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