1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION

Lithotriptor, Electro-hydraulic

NORTHGATE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for 1.9 French Lithotripter Electrode, Modification.

Pre-market Notification Details

Device IDK913955
510k NumberK913955
Device Name:1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
ClassificationLithotriptor, Electro-hydraulic
Applicant NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights,  IL  60004
ContactScott K Gilchrist
CorrespondentScott K Gilchrist
NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights,  IL  60004
Product CodeFFK  
CFR Regulation Number876.4480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-05
Decision Date1991-11-29

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