FDA 510(k) Application Details - K113247

Device Classification Name	Syringe, Cartridge   More FDA Info for this Device
510(K) Number	K113247
Device Name	Syringe, Cartridge
Applicant	KI WORKS CO., LTD. MIGUN TECHNOWOLRD 2 C-DONG 524 #533-1 YONGSAN-DONG, DAEJEON KS KR Other 510(k) Applications for this Company
Contact	EILEEN YANG Other 510(k) Applications for this Contact
Regulation Number	872.6770   More FDA Info for this Regulation Number
Classification Product Code	EJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2011
Decision Date	03/27/2012
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