A-dec NLZ Electric Motor System

Controller, Foot, Handpiece And Cord

NAKANISHI, INC.

The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for A-dec Nlz Electric Motor System.

Pre-market Notification Details

Device IDK163131
510k NumberK163131
Device Name:A-dec NLZ Electric Motor System
ClassificationController, Foot, Handpiece And Cord
Applicant NAKANISHI, INC. 700 SHIMOHINATA Kanuma-shi,  JP 322-8666
ContactKimihiko Satoh
CorrespondentIzumi Maruo
MIC INTERNATIONAL CORP. 4-1-17 HONGO Bunkyo-ku,  JP 1130033
Product CodeEBW  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-08
Decision Date2017-05-11
Summary:summary

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