FDA 510(k) Application Details - K110840

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K110840
Device Name	Accelerator, Linear, Medical
Applicant	SORDINA S.P.A. 110 E. GRANADA BLVD SUITE 207 ORMOND BEACH, FL 32176 US Other 510(k) Applications for this Company
Contact	BERTHOIN CLAUDE Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2011
Decision Date	04/17/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review