FDA 510(k) Application Details - K043581

Device Classification Name	Catheter, Ureteral, Gastro-Urology   More FDA Info for this Device
510(K) Number	K043581
Device Name	Catheter, Ureteral, Gastro-Urology
Applicant	ACMI CORPORATION 136 TURNPIKE RD. SOUTHBOROUGH, MA 01772 US Other 510(k) Applications for this Company
Contact	GRAHAM BAILLIE Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2004
Decision Date	03/03/2005
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