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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 K973630
Device Name CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/24/1997
Decision Date 12/05/1997
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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