FDA 510(k) Application Details - K062730

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K062730
Device Name	Condom
Applicant	BIOGREEN MEDICAL SDN. BHD. OFF 3/4 MILE JALAN BERCHAM KAWASAN PERINDUSTRIAN BERCHAM IPOH, PERAK 31400 MY Other 510(k) Applications for this Company
Contact	SRI MAHENDRA SATHIACAMA 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	09/13/2006
Decision Date	10/05/2006
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