FDA 510(k) Application Details - K091391

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K091391
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	UROPLASTY, INC. 5420 FELTL RD. MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	MICHAEL MORRELL Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2009
Decision Date	06/30/2009
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	N
Expedited Review