FDA 510(k) Application Details - K070939

Device Classification Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter   More FDA Info for this Device
510(K) Number	K070939
Device Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant	COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	REBEKA STOLTMAN 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	04/04/2007
Decision Date	06/01/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review