FDA 510(k) Application Details - K964322

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K964322
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	TILANE CORP. 1257 FLORIDA AVE. ROCKLEDGE, FL 32955 US Other 510(k) Applications for this Company
Contact	TIMOTHY G LANE MD, PH.D. Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/1996
Decision Date	02/26/1997
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