FDA 510(k) Application Details - K093068

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K093068
Device Name	Instrument, Biopsy
Applicant	C.R. BARD, INC. 1415 W. 3RD P.O BOX 1740 TEMPE, AZ 85280-1740 US Other 510(k) Applications for this Company
Contact	CINDY MOSS Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2009
Decision Date	11/10/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review