FDA 510(k) Application Details - K072747

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K072747
Device Name	Condom
Applicant	UNIDUS CORP. 507 SHALLOW CREEK ROAD TUSCALOOSA, AL 35406 US Other 510(k) Applications for this Company
Contact	CLAUDE L WRIGHT 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	09/27/2007
Decision Date	11/15/2007
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