FDA 510(k) Application Details - K991049

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K991049
Device Name	Condom
Applicant	MEDILATEX SDN. BHD. LOT PTB 500, PERINDUSTRIAN PKT2, BANDAR TENGGARA KULAI, JOHOR 81000 MY Other 510(k) Applications for this Company
Contact	LEE KIM LANG 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	03/30/1999
Decision Date	06/15/1999
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