FDA 510(k) Application Details - K070800

Device Classification Name	Condom, Synthetic   More FDA Info for this Device
510(K) Number	K070800
Device Name	Condom, Synthetic
Applicant	ANSELL HEALTHCARE PRODUCTS LLC 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	MOL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2007
Decision Date	03/06/2008
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