FDA 510(k) Application Details - K052134

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K052134
Device Name	Accessories, Catheter, G-U
Applicant	PERCUTANEOUS SYSTEMS, INC. 1300 CRITTENDEN LANE SUITE 101 MOUNTAIN VIEW, CA 94043-1359 US Other 510(k) Applications for this Company
Contact	THOMAS LAWSON 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	08/05/2005
Decision Date	09/22/2005
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