FDA 510(k) Application Details - K011180

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K011180
Device Name	System, X-Ray, Tomography, Computed
Applicant	COLUMBIA SCIENTIFIC, INC. 8940 OLD ANNAPOLIS RD. COLUMBIA, MD 21045 US Other 510(k) Applications for this Company
Contact	CHARLES D STOCKHAM Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2001
Decision Date	06/27/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review