FDA 510(k) Application Details - K080833

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K080833
Device Name	Condom
Applicant	TIANJIN HUMAN-CARE LATEX CORPORATION 56 DANVILLE DRIVE WEST WINDSOR, NJ 08550 US Other 510(k) Applications for this Company
Contact	SIMON LI 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	03/25/2008
Decision Date	08/07/2008
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