FDA 510(k) Application Details - K013773

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K013773
Device Name	Condom
Applicant	SSN MEDICAL PRODUCTS SDN. BHD. NO. 1, JALAN 203, OFF JALAN TANDANG PETALING JAYA, SELANGOR 46050 MY Other 510(k) Applications for this Company
Contact	ANG TECK LEONG 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	11/13/2001
Decision Date	01/24/2002
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