FDA 510(k) Application Details - K971627

Device Classification Name	Catheter, Urological (Antimicrobial) And Accessories   More FDA Info for this Device
510(K) Number	K971627
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	RICHARD D FRYAR 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	05/02/1997
Decision Date	01/13/1998
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