FDA 510(k) Application Details - K053279

Device Classification Name	More FDA Info for this Device
510(K) Number	K053279
Device Name	UROVANTAGE
Applicant	PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2005
Decision Date	12/22/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review