FDA 510(k) Application Details - K051288

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K051288
Device Name	Condom
Applicant	CST MEDICAL LIMITED 1676 VILLAGE GREEN SUITE A CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	Christian Smith 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	05/18/2005
Decision Date	02/03/2006
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	N
Expedited Review