FDA 510(k) Application Details - K163131

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K163131
Device Name	Controller, Foot, Handpiece And Cord
Applicant	NAKANISHI, INC. 700 SHIMOHINATA KANUMA-SHI 322-8666 JP Other 510(k) Applications for this Company
Contact	KIMIHIKO SATOH Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2016
Decision Date	05/11/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review