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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K163402
Device Name NLZ Motor System
Applicant
Nakanishi, Inc.
700 Shimohinata
Kanuma,  JP 322-8666
Applicant Contact Kimihiko Satoh
Correspondent
Mic International Corp.
4-1-17 Hongo
Bunkyo-Ku,  JP 1130033
Correspondent Contact Izumi Maruo
Regulation Number872.4200
Classification Product Code
EBW  
Subsequent Product Code
EGS  
Date Received12/05/2016
Decision Date 08/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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