CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE

Electrode, Needle

NICOLET BIOMEDICAL INSTRUMENTS

The following data is part of a premarket notification filed by Nicolet Biomedical Instruments with the FDA for Concentric Needle Electrodes-various Sizes W/conne.

Pre-market Notification Details

Device IDK850107
510k NumberK850107
Device Name:CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
ClassificationElectrode, Needle
Applicant NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison,  WI  53711
ContactRon Luich
CorrespondentRon Luich
NICOLET BIOMEDICAL INSTRUMENTS 5225-4 VERONA RD. P.O. BOX 4287 Madison,  WI  53711
Product CodeGXZ  
CFR Regulation Number882.1350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-10
Decision Date1985-04-11

NIH GUDID Devices

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