FDA 510(k) Application Details - K062788

Device Classification Name	Device, Beam Limiting, X-Ray, Diagnostic   More FDA Info for this Device
510(K) Number	K062788
Device Name	Device, Beam Limiting, X-Ray, Diagnostic
Applicant	UMI INTERNATIONAL 129 KENSINGTON AVE. NORWOOD, NJ 07648 US Other 510(k) Applications for this Company
Contact	KWANG C JUNG Other 510(k) Applications for this Contact
Regulation Number	892.1610   More FDA Info for this Regulation Number
Classification Product Code	KPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2006
Decision Date	12/28/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review