FDA 510(k) Application Details - K010178

Device Classification Name	Condom With Nonoxynol-9   More FDA Info for this Device
510(K) Number	K010178
Device Name	Condom With Nonoxynol-9
Applicant	INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG SHAH ALAM, SELANGOR D.E. 40150 MY Other 510(k) Applications for this Company
Contact	CHANG AU-KAU Other 510(k) Applications for this Contact
Regulation Number	884.5310   More FDA Info for this Regulation Number
Classification Product Code	LTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2001
Decision Date	04/27/2001
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