FDA 510(k) Application Details - K081491

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K081491
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	SMITH & NEPHEW, INC. 1450 E BROOKS ROAD MEMPHIS, TN 38116 US Other 510(k) Applications for this Company
Contact	MASON W ROBBINS 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	05/28/2008
Decision Date	06/19/2008
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