FDA 510(k) Application Details - K132570

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K132570
Device Name	Controller, Foot, Handpiece And Cord
Applicant	TTBIO CORP. 2F, NO.7, 6TH ROAD INDUSTRY PARK TAICHUNG, ROC 40755 TW Other 510(k) Applications for this Company
Contact	SHU-CHING LEE 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	08/15/2013
Decision Date	04/29/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review