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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 K945293
Device Name TOP ACOM STATION
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
ROENTGEN ANGIOGRAPHY CHICAGO
2501 N. BARRINGTON ROAD
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact PAUL H ORIS
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
ROENTGEN ANGIOGRAPHY CHICAGO
2501 N. BARRINGTON ROAD
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact PAUL H ORIS
Regulation Number892.1600
Classification Product Code
IZI  
Date Received10/31/1994
Decision Date 01/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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