FDA 510(k) Application Details - K981611

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K981611
Device Name	Accessories, Catheter, G-U
Applicant	CIRCON CORP. 6500 HOLLISTER AVE. SANTA BARBARA, CA 93117-3019 US Other 510(k) Applications for this Company
Contact	RONALD J EHMSEN Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/1998
Decision Date	07/30/1998
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