FDA 510(k) Application Details - K051055

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K051055
Device Name	System, Therapeutic, X-Ray
Applicant	CARL ZEISS SURGICAL GMBH 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2005
Decision Date	05/23/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review