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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K994315
Device Name CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact JAMIE YIEH
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact JAMIE YIEH
Regulation Number892.1000
Classification Product Code
MOS  
Date Received12/22/1999
Decision Date 02/04/2000
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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