FDA 510(k) Application Details - K043241

Device Classification Name	Catheter, Urethral   More FDA Info for this Device
510(K) Number	K043241
Device Name	Catheter, Urethral
Applicant	ASTRA TECH, INC. 20 MAIN STREET NORTHBOROUGH, MA 01532 US Other 510(k) Applications for this Company
Contact	BRUCE MANNING 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	11/23/2004
Decision Date	12/23/2004
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