FDA 510(k) Application Details - K031574

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K031574
Device Name	System, X-Ray, Mammographic
Applicant	S & S X-RAY PRODUCTS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK Other 510(k) Applications for this Contact
Regulation Number	892.1710   More FDA Info for this Regulation Number
Classification Product Code	IZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2003
Decision Date	08/04/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review