FDA 510(k) Application Details - K111616

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K111616
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	SAESHIN PRECISION CO., LTD. #93-15, PAHO-DONG, DALSEO-GU DAEGU 704-220 KR Other 510(k) Applications for this Company
Contact	Y S LEE Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2011
Decision Date	08/19/2011
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	Y
Expedited Review