FDA 510(k) Application Details - K962613

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K962613
Device Name	System, Therapeutic, X-Ray
Applicant	GULMAY MEDICAL LTD. UNIT 7, SHEPPERTON BUSINESS PARK, GOVETT AVENUE SHEPPERTON, MIDDLESEX TW17 8BA GB Other 510(k) Applications for this Company
Contact	G. CONDLIFFE Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/1996
Decision Date	09/27/1996
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