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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K984224
Device Name PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
Applicant
SIEMENS CORP.
186 WOOD AVE., SOUTH
ISELIN,  NJ  08830
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
SIEMENS CORP.
186 WOOD AVE., SOUTH
ISELIN,  NJ  08830
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/25/1998
Decision Date 02/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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