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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 K010721
Device Name AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
Applicant
SIEMENS MEDICAL CORP.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Applicant Contact PRAVEEN NADKARNI
Correspondent
SIEMENS MEDICAL CORP.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Correspondent Contact PRAVEEN NADKARNI
Regulation Number892.1600
Classification Product Code
IZI  
Date Received03/12/2001
Decision Date 03/30/2001
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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