FDA 510(k) Application Details - K073328

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K073328
Device Name	System, X-Ray, Angiographic
Applicant	PAIEON, INC. 22 HAMELACHA ST., P.O.B. 11355 ROSH HAAYIN 48901 IL Other 510(k) Applications for this Company
Contact	RAVIT BARKAMA Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2007
Decision Date	09/09/2008
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