FDA 510(k) Application Details - K113536

Device Classification Name	Lacrimal Stents And Intubation Sets   More FDA Info for this Device
510(K) Number	K113536
Device Name	Lacrimal Stents And Intubation Sets
Applicant	FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) 3308 JEFFERSON AVENUE UPPER LEVEL CINCINNATI, OH 45220 US Other 510(k) Applications for this Company
Contact	BARBARA FRANT Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OKS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2011
Decision Date	08/03/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review