FDA 510(k) Application Details - K973834

Device Classification Name	System, X-Ray, Tomographic   More FDA Info for this Device
510(K) Number	K973834
Device Name	System, X-Ray, Tomographic
Applicant	PAUSCH CORP. 808 SHREWSBURY AVE. TENTON FALLS, NJ 07724 US Other 510(k) Applications for this Company
Contact	KENNETH TICE Other 510(k) Applications for this Contact
Regulation Number	892.1740   More FDA Info for this Regulation Number
Classification Product Code	IZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/1997
Decision Date	04/30/1998
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