FDA 510(k) Application Details - K121579

Device Classification Name	More FDA Info for this Device
510(K) Number	K121579
Device Name	EK DELIVERY DEVICE
Applicant	TDAK MEDICAL, INC 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2012
Decision Date	10/03/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review