CONCENTRIC EMG NEEDLE ELECTRODE

Electrode, Needle

CADWELL LABORATORIES, INC.

The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Concentric Emg Needle Electrode.

Pre-market Notification Details

Device IDK933795
510k NumberK933795
Device Name:CONCENTRIC EMG NEEDLE ELECTRODE
ClassificationElectrode, Needle
Applicant CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick,  WA  99336
ContactCarlton M Cadwell
CorrespondentCarlton M Cadwell
CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick,  WA  99336
Product CodeGXZ  
CFR Regulation Number882.1350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-04
Decision Date1994-04-22

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