NEURO N 50 LESION GENERATOR

Generator, Lesion, Radiofrequency

LEIBINGER & FISCHER LTD.

The following data is part of a premarket notification filed by Leibinger & Fischer Ltd. with the FDA for Neuro N 50 Lesion Generator.

Pre-market Notification Details

Device IDK896450
510k NumberK896450
Device Name:NEURO N 50 LESION GENERATOR
ClassificationGenerator, Lesion, Radiofrequency
Applicant LEIBINGER & FISCHER LTD. 4500 TRAMMELL CROW CENTER 2001 ROSS AVENUE Dallas,  TX  75201
ContactPaul Stewart
CorrespondentPaul Stewart
LEIBINGER & FISCHER LTD. 4500 TRAMMELL CROW CENTER 2001 ROSS AVENUE Dallas,  TX  75201
Product CodeGXD  
CFR Regulation Number882.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-09
Decision Date1991-03-19

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