FDA 510(k) Application Details - K982380

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K982380
Device Name	Condom
Applicant	PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG JERAM, SELANGOR 45800 MY Other 510(k) Applications for this Company
Contact	CHANG AH KAU 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	07/08/1998
Decision Date	02/26/1999
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