FDA 510(k) Application Details - K982890

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K982890
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. ST. PAUL, MN 55110 US Other 510(k) Applications for this Company
Contact	KAREN E PETERSON 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	08/17/1998
Decision Date	10/26/1998
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