FDA 510(k) Application Details - K120555

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K120555
Device Name	Condom
Applicant	MEDICAL-LATEX (DUA) SDN. BHD PLO 8 SENAI INDUSTRIAL ESTATE SENAI 81400 MY Other 510(k) Applications for this Company
Contact	UMA DEVI 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	02/23/2012
Decision Date	11/02/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review