FDA 510(k) Application Details - K051273

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K051273
Device Name	Condom
Applicant	EAGLE TWE, INC. 2090 TUCKER INDUSTRIAL ROAD SUITE A-5 TUCKER, GA 30084 US Other 510(k) Applications for this Company
Contact	BILL TAFFS 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	05/17/2005
Decision Date	08/19/2005
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