FDA 510(k) Application Details - K053367

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K053367
Device Name	Condom
Applicant	INNOLATEX SDN. BHD PANDAMARAN INDUSTRIAL ESTATE PORT KLANG SELANGOR DARUL EHSAN 42000 MY Other 510(k) Applications for this Company
Contact	GOH MIAH KIAT 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	12/05/2005
Decision Date	02/21/2006
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