FDA 510(k) Application Details - K042957

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K042957
Device Name	Condom
Applicant	SSL AMERICAS 3583 ENGINEERING DR. SUITE 200 NORCROSS, GA 30092 US Other 510(k) Applications for this Company
Contact	CHRIS ROBINSON 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	10/27/2004
Decision Date	02/17/2005
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