FDA 510(k) Application Details - K150743

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K150743
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	KAREX INDUSTRIES SDN. BHD. PTD 7906 & 7907, TAMAN PONTIAN JAYA, BATU 34, JALAN JOHOR PONTIAN 82000 MY Other 510(k) Applications for this Company
Contact	MS. MARY GOH YIN 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	03/23/2015
Decision Date	11/12/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review