FDA 510(k) Application Details - K083817

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K083817
Device Name	Condom
Applicant	SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. RM. 1606, BLDG. 1, JIANXIANG - YUAN NO.209 BEI SI HUAN ZHONG HAIDIAN DISTRICT, BEIJING 100083 CN Other 510(k) Applications for this Company
Contact	CHU XIAOAN 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	12/22/2008
Decision Date	09/16/2009
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