FDA 510(k) Application Details - K081265

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K081265
Device Name	Condom
Applicant	THAI NIPPON RUBBER INDUSTRY CO., LTD. PO BOX 12139 DURHAM, NC 27709 US Other 510(k) Applications for this Company
Contact	ELI J CARTER 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	05/05/2008
Decision Date	10/16/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review