FDA 510(k) Application Details - K994118

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K994118
Device Name	Condom
Applicant	GUILIN LATEX FACTORY 93 MORNINGSIDE DR. SAN FRANCISCO, CA 94132 US Other 510(k) Applications for this Company
Contact	PETER WEI 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	12/06/1999
Decision Date	08/14/2000
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