FDA 510(k) Application Details - K980964

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K980964
Device Name	Condom
Applicant	LS RUBBER SDN BHD 2443 FILLMORE ST. SUITE 135 SAN FRANCISCO, CA 91115 US Other 510(k) Applications for this Company
Contact	MOHAMAD FIRDAOS BIN MOHAMED 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	03/16/1998
Decision Date	03/12/1999
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