FDA 510(k) Application Details - K060908

Device Classification Name	More FDA Info for this Device
510(K) Number	K060908
Device Name	SONOHYSTEROGRAPHY BIOPSY DEVICE
Applicant	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. SPENCER, IN 47460 US Other 510(k) Applications for this Company
Contact	CINDY RUMPLE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2006
Decision Date	06/29/2006
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	N
Expedited Review