FDA 510(k) Application Details - K043605

Device Classification Name	Dilator, Esophageal   More FDA Info for this Device
510(K) Number	K043605
Device Name	Dilator, Esophageal
Applicant	CORDIS EUROPA, N.V. OOSTEINDE 8 RODEN NL-9301 LJ NL Other 510(k) Applications for this Company
Contact	HARM HOVINGA Other 510(k) Applications for this Contact
Regulation Number	876.5365   More FDA Info for this Regulation Number
Classification Product Code	KNQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2004
Decision Date	02/04/2005
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