FDA 510(k) Application Details - K082939

Device Classification Name	Instrument, Manual, Specialized Obstetric-Gynecologic   More FDA Info for this Device
510(K) Number	K082939
Device Name	Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant	COOK UROLOGICAL, INC. 750 DANIELS WAY BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	CINDY FOOTE Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	KNA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2008
Decision Date	09/03/2009
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