FDA 510(k) Application Details - K953813

Device Classification Name	Condom With Nonoxynol-9   More FDA Info for this Device
510(K) Number	K953813
Device Name	Condom With Nonoxynol-9
Applicant	LONDON INTERNATIONAL U.S. HOLDINGS, INC. 1819 MAIN ST., 8TH FLOOR P.O. BOX 4703 SARASOTA, FL 34236 US Other 510(k) Applications for this Company
Contact	PHYLISS M BARBER Other 510(k) Applications for this Contact
Regulation Number	884.5310   More FDA Info for this Regulation Number
Classification Product Code	LTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/1995
Decision Date	07/22/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review