FDA 510(k) Application Details - K011055

Device Classification Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter   More FDA Info for this Device
510(K) Number	K011055
Device Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant	GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. SUBIACO, PERTH 6008 AU Other 510(k) Applications for this Company
Contact	GEORGE O'NEIL Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	FCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2001
Decision Date	06/06/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review