FDA 510(k) Application Details - K141482

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K141482
Device Name	Controller, Foot, Handpiece And Cord
Applicant	SAEYANG MICROTECH CO LTD 2651 E.CHAPMAN AVE STE 110 FULLERTON, CA 92831 US Other 510(k) Applications for this Company
Contact	Priscilla Chung 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	06/04/2014
Decision Date	04/24/2015
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