FDA 510(k) Application Details - K110856

Device Classification Name	Collimator, Manual, Radiographic   More FDA Info for this Device
510(K) Number	K110856
Device Name	Collimator, Manual, Radiographic
Applicant	RALCO S.R.L. 8870 RAVELLO CT NAPLES, FL 34114 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	892.1610   More FDA Info for this Regulation Number
Classification Product Code	IZX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2011
Decision Date	08/10/2011
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