FDA 510(k) Application Details - K983017

Device Classification Name	Washer, Cleaner, Automated, Endoscope   More FDA Info for this Device
510(K) Number	K983017
Device Name	Washer, Cleaner, Automated, Endoscope
Applicant	CUSTOM ULTRASONICS 144 RAILROAD DR. IVYLAND, PA 18974 US Other 510(k) Applications for this Company
Contact	FRANK J WEBER 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	08/28/1998
Decision Date	09/22/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review