FDA 510(k) Application Details - K092586

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K092586
Device Name	Condom
Applicant	INNOLATEX (THAILAND) LIMITED SOUTHERN INDUSTRIAL ESTATE VILLAGE 4 CHALUNG SUB-DISTRICT HATYAI DISTRICT, SONGKHLA 90110 TH Other 510(k) Applications for this Company
Contact	GOH SAING 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	08/24/2009
Decision Date	05/12/2010
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