FDA 510(k) Application Details - K063795

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K063795
Device Name	Catheter, Urethral
Applicant	MARIAN MEDICAL, INC. 319 WESTPORT DR. LOUISVILLE, KY 40207 US Other 510(k) Applications for this Company
Contact	SANDRA WINKLER Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	GBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2006
Decision Date	03/05/2007
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