FDA 510(k) Application Details - K034021

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K034021
Device Name	Instrument, Biopsy
Applicant	SUROS SURGICAL SYSTEMS, INC. 9502 ANGOLA COURT SUITE 3 INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	JOSEPH L MARK 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	12/24/2003
Decision Date	09/08/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review