FDA 510(k) Application Details - K946103

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K946103
Device Name	Condom
Applicant	LINE ONE LABORATORIES & TRADING CO. P.O. BOX 861941 LOS ANGELES, CA 90086 US Other 510(k) Applications for this Company
Contact	BUDIMAN LEE 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	12/14/1994
Decision Date	07/15/1996
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