FDA 510(k) Application Details - DEN100016

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN100016
Device Name	PROSTATE MECHANICAL IMAGER
Applicant	ARTANN LABORATORIES, INC 555 13TH STREET NW COLUMBIA SQUARE WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	GERARD J PRUD'HOMME Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OQT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2010
Decision Date	04/27/2012
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review