FDA 510(k) Application Details - K060797

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K060797
Device Name	Condom
Applicant	VERAXIS INT'L INC. 261 MADISON AVENUE 24TH FLOOR NEW YORK, NY 10016 US Other 510(k) Applications for this Company
Contact	JULES T MITCHEL 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	03/24/2006
Decision Date	04/07/2006
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	Y
Expedited Review