FDA 510(k) Application Details - K002393

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K002393
Device Name	Condom
Applicant	INNOLATEX SDN. BHD NO 16, JALAN BULAN U5/5 BANDAR PINGGIRAN SUBANG, SHAH ALAM,SELANGOR DARUL EHSAN MY Other 510(k) Applications for this Company
Contact	CHANG AH-KAU 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	08/07/2000
Decision Date	12/19/2000
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