FDA 510(k) Application Details - K033076

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K033076
Device Name	Condom
Applicant	ANSELL HEALTHCARE, INC. 1635 INDUSTRIAL RD. DOTHAN, AL 36303 US Other 510(k) Applications for this Company
Contact	LON D MCILVAIN 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	09/29/2003
Decision Date	12/19/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review