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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K953563
Device Name VANGUARD XR-350 CINEANGIOGRAM PROJECTOR
Applicant
Jamieson Film Co.
10425 Olympic Dr.
Dallas,  TX  75220
Applicant Contact GEORGE LEON
Correspondent
Jamieson Film Co.
10425 Olympic Dr.
Dallas,  TX  75220
Correspondent Contact GEORGE LEON
Regulation Number892.1600
Classification Product Code
IZI  
Date Received07/31/1995
Decision Date 10/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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