FDA 510(k) Application Details - K142473

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K142473
Device Name	Lubricant, Patient
Applicant	SION BIOTEXT MEDICAL LTD KIBBUTZ HAGOSHRIM UPPER GALILEE 12225 IL Other 510(k) Applications for this Company
Contact	NADAV REUBEN Other 510(k) Applications for this Contact
Regulation Number	880.6375   More FDA Info for this Regulation Number
Classification Product Code	KMJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2014
Decision Date	04/13/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review