FDA 510(k) Application Details - K083109

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K083109
Device Name	System, X-Ray, Stationary
Applicant	SUINSA P.O. BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2008
Decision Date	12/04/2008
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