FDA 510(k) Application Details - K082066

Device Classification Name	Brush, Endometrial   More FDA Info for this Device
510(K) Number	K082066
Device Name	Brush, Endometrial
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	884.1100   More FDA Info for this Regulation Number
Classification Product Code	HFE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2008
Decision Date	11/07/2008
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