FDA 510(k) Application Details - DEN020001

Device Classification Name	System, Documentation, Breast Lesion   More FDA Info for this Device
510(K) Number	DEN020001
Device Name	System, Documentation, Breast Lesion
Applicant	ASSURANCE MEDICAL 555 THIRTEENTH STREET, N.W. WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN Other 510(k) Applications for this Contact
Regulation Number	884.2990   More FDA Info for this Regulation Number
Classification Product Code	NKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2002
Decision Date	01/31/2003
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review