FDA 510(k) Application Details - K023229

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K023229
Device Name	System, X-Ray, Mammographic
Applicant	AMERICAN MAMMOGRAPHICS, INC. 1302 SHAWHAN TERRACE CHATTANOOGA, TN 37411 US Other 510(k) Applications for this Company
Contact	ADRIAN PALMER 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	09/27/2002
Decision Date	12/13/2002
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