FDA 510(k) Application Details - K011926

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K011926
Device Name	Controller, Foot, Handpiece And Cord
Applicant	NAKANISHI, INC. 340 KAMIHINATA, KANUMA-SHI TOCHIGI-KEN 322 JP Other 510(k) Applications for this Company
Contact	HIROJI SEKIGUCHI 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	06/20/2001
Decision Date	09/11/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review