FDA 510(k) Application Details - K081768

Device Classification Name	Agents,Embolic,For Treatment Of Uterine Fibroids   More FDA Info for this Device
510(K) Number	K081768
Device Name	Agents,Embolic,For Treatment Of Uterine Fibroids
Applicant	COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	SUSANNE GALIN Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	NAJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2008
Decision Date	12/23/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review