FDA 510(k) Application Details - K132597

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K132597
Device Name	Condom
Applicant	KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR PONTIAN, JOHOR 82000 MY Other 510(k) Applications for this Company
Contact	MARY GOH YIN Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	HIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2013
Decision Date	11/25/2013
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