FDA 510(k) Application Details - K002640

Device Classification Name	Processor, Radiographic-Film, Automatic   More FDA Info for this Device
510(K) Number	K002640
Device Name	Processor, Radiographic-Film, Automatic
Applicant	J. MORITA USA, INC. 9 MASON IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	VICTOR MAZZANTI Other 510(k) Applications for this Contact
Regulation Number	892.1900   More FDA Info for this Regulation Number
Classification Product Code	IXW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2000
Decision Date	11/08/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review