FDA 510(k) Application Details - K001583

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K001583
Device Name	Catheter, Urological
Applicant	ISLAND BIOSURGICAL, LLC. 18 MEADOW LN. MERCER ISLAND, WA 98040-5340 US Other 510(k) Applications for this Company
Contact	HUNTER A MCKAY Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2000
Decision Date	07/13/2000
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