FDA 510(k) Application Details - K970738

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K970738
Device Name	System, X-Ray, Angiographic
Applicant	JAMIESON FILM CO. HEALTH SCIENCES DIVISION 901 ELMGROVE ROAD ROCHESTER, NY 14653-5741 US Other 510(k) Applications for this Company
Contact	DAN NEWMAN Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/1997
Decision Date	05/07/1997
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