FDA 510(k) Application Details - K141913

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K141913
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	PJUR GROUP LUXEMBOURG SA 722 ARJEAN DRIVE WILMINGTON, NC 28411 US Other 510(k) Applications for this Company
Contact	CANDACE F CEDERMAN Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	NUC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2014
Decision Date	04/06/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review