FDA 510(k) Application Details - K170247

Device Classification Name	Lacrimal Stents And Intubation Sets   More FDA Info for this Device
510(K) Number	K170247
Device Name	Lacrimal Stents And Intubation Sets
Applicant	KANEKA PHARMA AMERICA LLC 546 FIFTH AVE., 21ST FLOOR NEW YORK, NY 10036 US Other 510(k) Applications for this Company
Contact	Masaaki Fukunishi 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	01/27/2017
Decision Date	04/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review