FDA 510(k) Application Details - K043314

Device Classification Name	Washer, Cleaner, Automated, Endoscope   More FDA Info for this Device
510(K) Number	K043314
Device Name	Washer, Cleaner, Automated, Endoscope
Applicant	LANGFORD IC SYSTEMS, INC. 310 S. WILLIAMS BLVD. SUITE 270 TUCSON, AZ 85711 US Other 510(k) Applications for this Company
Contact	TERRY LANGFORD Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2004
Decision Date	06/20/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review