FDA 510(k) Application Details - K945145

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K945145
Device Name	Condom
Applicant	MBF PERSONAL CARE SDN. BHD. PLO 22,SENAI INDUSTRIAL ESTATE PHASE 1 81400 SENAI, JOHOR 81400 MY Other 510(k) Applications for this Company
Contact	P K REDDY 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	10/20/1994
Decision Date	02/21/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review