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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 Rd.
Hoffman Estates,  IL  60195
Applicant Contact PAUL H ORIS
Correspondent
Siemens Medical Solutions USA, Inc.
Roentgen Angiography Chicago
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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