FDA 510(k) Application Details - K001143

Device Classification Name	Catheter, Urological (Antimicrobial) And Accessories   More FDA Info for this Device
510(K) Number	K001143
Device Name	Catheter, Urological (Antimicrobial) And Accessories
Applicant	ROCHESTER MEDICAL CORP. ONE ROCHESTER MEDICAL DR. STEWARTVILLE, MN 55976 US Other 510(k) Applications for this Company
Contact	MARY WILEN Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	MJC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2000
Decision Date	07/07/2000
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