FDA 510(k) Application Details - K081413

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K081413
Device Name	Condom
Applicant	DAILIAN LATEX COMPANY, LTD. NO. 188 MALAN NORTH STREET SHAHEKOU DISTRICT DAILIAN CITY, LIAONING 116021 CN Other 510(k) Applications for this Company
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	05/20/2008
Decision Date	10/24/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review